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Cardiothoracic Surgical Trials Network (CTSN) Investigator Meeting
May 19 - 21, 2014
Renaissance Arlington Capital View Hotel
2800 South Potomac Avenue, Arlington, VA
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Table of Contents
Agendas ........................................................................................................... 1
Research Coordinator Meeting ...................................................... 1
LVAD MPC II Trial Investigator Meeting ................................... 2
Investigator Meeting ........................................................................ 3
Neurocognitive Training ................................................................. 4
CTSN Participants ......................................................................................... 7
CTSN Study Overview ................................................................................ 15
Trial Synopses .............................................................................................. 17
CTSN Site Participation .............................................................................. 32
Selected Publications ................................................................................... 33
Meeting Attendees ....................................................................................... 35
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Cardiothoracic Surgical Trials Network Research Coordinator Meeting
Monday, May 19, 2014 Renaissance Arlington Capital View Hotel · 2800 South Potomac Avenue, Arlington, VA
12:00 PM Luncheon Buffet
12:15 PM Welcome and Trial Updates
Current Trials Prospective Studies and Timelines
12:30 PM Regulatory and Monitoring Updates
Revised Method for Protocol Deviation Submission
Invoices and Payments
FDA Audit: Lessons Learned (Sandra Burks)
1:00 PM Postoperative AF Trial Overview
Recruitment & Randomization Remote Heart Monitor Coordination & Logistics Frequently Asked Questions, including:
o 48 hr. Cardioversion o Hospitalization Classifications o Source Document Requirements
POAF Excel Program (Mary Lou Mayer & Stephen Cresse)
2:30 PM Question and Answer Session
For sites participating in the LVAD MPC II Trial, the meeting will continue with the below agenda.
3:00 PM LVAD MPC Trial Overview
3:15 PM LVAD MPC II Trial Protocol Review
4:00 PM Clinical Site Trial Management and Enrollment Experiences
Study Start-up o Stem Cell Laboratory Logistics o Determining Screening HLA
Study Visit Organization
Intervention Day Supervision o Time Management o Intra-operative Tissue Collection & Processing
LVAD Wean Coordination
4:45 PM Question and Answer Session
5:00 PM Adjourn
The DCC will be hosting a dinner for all the coordinators at 6:30 pm at Jaleo Crystal City (2250 Crystal
Dr, Arlington, VA 22202). We hope that you will be able to join us.
1
Cardiothoracic Surgical Trials Network (CTSN) LVAD MPC II Trial Investigator Meeting
Tuesday, May 20, 2014 Renaissance Arlington Capital View Hotel · 2800 South Potomac Avenue, Arlington, VA
8:00 AM Welcome and Trial Overview
Study Background and Rationale
Study Objectives
Study Design & Population
Study Endpoints
8:15 AM Randomization & Treatment Intervention
Randomization Procedures & Requirements Treatment Intervention: Review of LVAD Implant & Injection Procedure
8:30 AM Trial Discussion & Questions
Study Personnel Roles and Responsibilities Screening and Enrollment Plan Study Product Delivery, Storage and Dispensing Treatment Day Coordination LVAD Wean Logistics
8:55 AM Adjourn
2
Cardiothoracic Surgical Trials Network (CTSN) Investigator Meeting
Tuesday, May 20, 2014 Renaissance Arlington Capital View Hotel
Salon 4 of the Ballroom 2800 South Potomac Avenue, Arlington, VA
Dial (866) 453-5550; PIN: 8071907#
8:00 AM LVAD/MPC Trial Investigator training See separate agenda
9:00 AM Continental Breakfast
10:00 AM Welcome and Meeting Overview
Gardner, O’Gara, DCC, NHLBI 10:05 AM The Role of the PI in CTSN Trials Taddei-Peters
CURRENT TRIAL ACTIVITY
10:25 AM Post-Operative AF Trial: Early Lessons Learned
Moderators: Gillinov/O’Gara Panel: Bowdish, Argenziano, Bolling, Burks, DCC 10:55 AM MPC/LVAD Trial II Acker, Yau, Mayer, DCC 11:10 AM FFR-Guided Surgical Revascularization Trial Smith, Alexander, DCC 11:40 AM Embolic Protection Device Trial Mack, Acker, Thourani, Messé, DCC
NEW TRIAL PROPOSALS
12:10 PM Use of Life Vest in post-op CABG patients with LV dysfunction Lytle, Chung 12:30 PM Luncheon Buffet
1:00 PM Tricuspid Annuloplasty for Moderate TR Associated with Mitral Valve Surgery Gammie 1:20 PM Serca 2a Gene Therapy Rose, D’Alessandro, Michler, DCC 1:40 PM Use of Novel Oral Anticoagulants Post-Operatively in Cardiac Surgery Patients O’Gara, DCC 2:00 PM Remote Ischemic Preconditioning
Messé, Horvath, DCC
OTHER POSSIBLE CTSN COLLABORATIONS
2:20 PM LIBERTI and TRICS Trials
Perrault 2:40 PM Left Atrial Appendage Occlusion Study (LAAOS) Ailawadi DISSEMINATION PLANS OF CURRENT CTSN TRIALS
3:00 PM Publications and Presentations
O’Gara, DCC 3:20 PM Wrap-Up and Adjourn
Gardner, DCC
3
Cardiothoracic Surgical Trials Network CTSN Neurocognitive Battery Training
Tuesday, May 20, 2014 Renaissance Arlington Capital View Hotel · 2800 South Potomac Avenue, Arlington, VA
CTSN Neurocognitive Battery Training Agenda
Investigators: Dr. Joseph Mathew – Co-PI Dr. Jeffrey Browndyke – Co-PI Presenter: Dr. Jeffrey Browndyke, Clinical Neuropsychologist Trainers: Yanne Toulgoat Dubois Rachele Brassard 3:00 PM: Introduction to the CTSN Neurocognitive/ COWA, Administration Issues
& Test Procedure Video Demonstration (Browndyke) 3:30 AM: CTSN Battery - Group Practice Session (All Participants) 4:00 PM: Individualized Practice with CTSN Trainers * 5:00 PM: Wrap Up
4
Cardiothoracic Surgical Trials Network CTSN Neurocognitive Battery Training
Wednesday, May 21, 2014 Renaissance Arlington Capital View Hotel · 2800 South Potomac Avenue, Arlington, VA
CTSN Neurocognitive Battery Training Agenda
Investigators: Dr. Joseph Mathew – Co-PI Dr. Jeffrey Browndyke – Co-PI Presenter: Dr. Jeffrey Browndyke, Clinical Neuropsychologist Trainers: Yanne Toulgoat Dubois Rachele Brassard 6:30 AM: Breakfast (30 minutes) 7:00 AM: Introduction to the CTSN Neurocognitive Battery, Administration Issues
& Test Procedure Video Demonstration (Browndyke) 8:15 AM: CTSN Battery - Group Practice Session (All Participants) 9:30 AM: Break (15 minutes) 9:45 AM: Individualized Practice with CTSN Trainers * 12:00 PM: Lunch Break (30 minutes) 12:30 PM: Continuation of Individualized Practice with CTSN Trainers * 4:15 PM: Wrap Up
5
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Cardiothoracic Surgical Trials Network 2014 Participants
Institution Name Role
Christiana Care Health System Timothy J. Gardner, MD CTSN Chair
Brigham & Women's Hospital Patrick T. O’Gara, MD CTSN Co-Chair
NIH and CIHR
National Heart Lung and Blood Institute
Marissa A. Miller, DVM, MPH Program Director
Albert Lee, PhD Deputy Program Director
Wendy C. Taddei-Peters, PhD Regulatory & CT Specialist
Nancy L. Geller, PhD Director, Office of Biostatistics Research
Neal Jeffries, PhD Office of Biostatistics Research
Amy Connolly Senior Grants Management Specialist
Teresa Marquette Grants Management Officer
Denis Buxton, PhD Cardiovascular Translational Research Specialist
David J. Gordon, MD, PhD Medical Officer
National Institute of Neurological Disorders and Stroke
Claudia S. Moy, PhD Program Director
Canadian Institutes of Health Research
Ilana K. Gombos, PhD Assistant Director
Jennifer Ralph Project Manager
CORE CLINICAL CENTERS
Baylor Research Institute Michael Mack, MD PI
The Heart Hospital at Baylor Plano
William Ryan, MD Investigator
Robert Smith, MD Investigator
Paul Grayburn, MD Investigator/ Cardiologist
William Brinkman, MD Investigator
Katherine Harrington, MD Investigator Kelley Hutcheson, MD Investigator David Moore, MD Investigator
Pedro Nosnik, MD Investigator Tracine Adame, RN, CRC Coordinator
Natalie Settele, PA-C Research Manager
Kristin Kirtland Coordinator
Amy Barnette Coordinator
Shelley Hall Coordinator
Renesa Whitman Coordinator
Irina Neretin Coordinator
Jessica Jones Coordinator
Lee Mary Sulkin, RN Coordinator
Jenny Adams, PhD CPX Lab
Claudia Mattil Research Director
Michael Johnson, CRC Coordinator
Baylor Heart and Vascular Hospital
Gonzalo Gonzalez, MD Investigator Themistokles Chamogeorgakis, MD Investigator Juan Carlos Machannaford, MD Investigator
Aldo Elmer Rafael, MD Investigator Alice Lorraine Kruger, RN Coordinator
Kimeshia Carrington Coordinator
Medical City Dallas CRISTI Todd Dewey, MD Investigator
Eric Eichhorn, MD Investigator/ Cardiologist Tina Worley, RN Coordinator
Melissa Johnson Coordinator
Cecile Mahoney, BS, CCRP Coordinator
7
Cardiothoracic Surgical Trials Network 2014 Participants
Institution Name Role
Medical City Dallas CRISTI cont. Darinka Savor, RN LVAD Coordinator
Marchelle Badon Cell Technician/Pharmacist
Soojin Kim Cell Technician/Pharmacist
Mark Bane Contracts
Cleveland Clinic Foundation Bruce Lytle, MD PI
A. Marc Gillinov, MD Investigator
Eugene Blackstone, MD Investigator
Kristin Doud Coordinator
Carrie L. Geither, RN Coordinator
Michelle Garica, RN Coordinator
Kathy Sankovic, RN, CCRP Coordinator
Pam Lackner Coordinator
Roberta Palumbo, RN Coordinator
Rory Hachamovitch, MD, MSc Echocardiologist
Farhang Yazdchi NIH Scholar
Denise Sweeney-Kosty Research Director Richard A. Grimm, DO, FACC, FASE Cardiologist
Randall C. Starling, MD, MPH Cardiologist
Benico Barzilai, MD, FACC Cardiologist
Eric Roselli, MD Investigator
Nicholas Smedira, MD Investigator
Nader Moazami, MD Investigator
Randall Starling, MD, MPH Investigator/ Cardiologist
Sangjin Lee, MD Investigator
Tiffany Buda, RN LVAD Coordinator
Carol Dumont Cell Technician/Pharmacist
Priscilla Figueroa, MD Cell Technician/Pharmacist
Cheryl Sterle Cell Technician/Pharmacist
Mark Jarosz Cell Technician/Pharmacist
Duke University Peter Smith, MD PI
John Alexander, MD Investigator Carmelo Milano, MD Investigator Donald Glower, MD Investigator Joel Huber, MD Investigator
Stacey Welsh, RN Coordinator
Victoria Sutton, CCRP, CRC II Coordinator
Chris Kolller Coordinator
Brian Gulack, MD NIH Scholar
Brian Englum, MD NIH Scholar Mark Berry, MD NIH Scholar Judson Williams, MD NIH Scholar Matthew Hartwig, MD Fellow Joseph G. Rogers, MD Investigator Chetan Patel, MD Investigator Laura Blue, NP LVAD Coordinator
Ann Kaestner Cell Technician/Pharmacist Barbara Waters-Pick, BS, MT(ASCP) Stem Cell Lab Manager
Dawn Bowles Cell Technician/Pharmacist
Annette Sullivan Contract Specialist
Lauren Shield Budgets Specialist
8
Cardiothoracic Surgical Trials Network 2014 Participants
Institution Name Role
Institut Universitaire de Cardiologie de Québec (Hôpital Laval)
Pierre Voisine, MD PI
François Dagenais, MD Investigator/ Cardiologist
Mario Senechal, MD Investigator/ Cardiologist
Kim O’Connor, MD Investigator/ Cardiologist
Gladys Dussault Coordinator
Hugo Tremblay Coordinator
Patricia Landry Coordinator
Suzanne Keilani Coordinator
Tatiana Ballivian Coordinator
Marie-Josée Goulet Coordinator
Montefiore Medical Center - Albert Einstein College of Medicine
Robert Michler, MD PI
David Arthur D'Alessandro, MD Investigator Joseph J. DeRose, Jr., MD Investigator Cynthia Taub, MD Investigator/ Cardiologist
Ricardo A. Bello, MD, PhD Investigator
Daniel J. Goldstein, MD Investigator Daniel Spevack, MD, FASE, FACC Investigator/ Cardiologist
Roger Swayze, RN, BSN, MBA Coordinator
Nadia Sookraj Coordinator
Juan Garcia Coordinator
Rebecca Meli Coordinator
Terry Grosso Administrator- Cardiology
Cecilia Nucci, RN, BSN LVAD Coordinator
Carlo Palesi Cell Technician/Pharmacist
Pearl Bongolan Cell Technician/Pharmacist
Clemencia Solorzano Cell Technician/Pharmacist
Danielle Casazza, RN Data Coordinator
Joe D'Errico Contracts Specialist
Montreal Heart Institute Louis Perrault, MD PI
Michel Carrier, MD Investigator
Denis Bouchard, MD Investigator
Jean-François Tanguay, MD Investigator
Sophie Robichaud, RT Coordinator
Jonathan Lacharité Coordinator
Centre Hospitalier de l'Université de Montréal (CHUM)
Nicolas Noiseux, MD PI
Louis-Mathieu Stevens, MD Investigator
Ignacio Prieto, MD Investigator
Fadi Basile, MD Investigator
Joannie Dionne Coordinator
Julie Fecteau Coordinator
Hôpital du Sacré-Cœur de Montréal
Hugues Jeanmart, MD PI
Pierre Pagé, MD Investigator
Carole Sirois Coordinator
NIH Heart Center at Suburban Hospital
Keith Horvath, MD PI
Philip Corcoran, MD Investigator
Michael Siegenthaler, MD Investigator
Greg Kumkumian, MD Cardiologist
Mark Milner, MD Cardiologist
Mandy Murphy, RN, CCRC Coordinator
Ann Greenberg, RN, MSN Coordinator
Peggy Iraola, RN, MPP Coordinator
Zurab Nadareishvili, MD, PhD Neurologist
9
Cardiothoracic Surgical Trials Network 2014 Participants
Institution Name Role
University of Pennsylvania Michael A. Acker, MD PI
Pavan Atluri Investigator
Steven Messe, MD Investigator/ Neurologist
William H. Matthai, MD Investigator/ Cardiologist
James Kirkpatrick, MD Cardiologist
Kenneth Margulies, MD Cardiologist Mary Lou Mayer, BSN, CCRN, CCRC
Coordinator
Katie Tremont, BS Coordinator
Stephen Cresse, BSN Coordinator
Joseph Y. Woo, MD Investigator
Kenneth Margulies, MD Investigator/ Cardiologist
J. Eduardo Rame, MD, M.Phil Investigator/ Cardiologist
Christyna Zalewski, BSN LVAD Coordinator
Alexandra Acker Coordinator
Alexey Bersenev Cell Technician/Pharmacist Jenna Lynn Milano, PharmD Cell Technician/Pharmacist Devangi Shah Cell Technician/Pharmacist Suzanne Pavluk Cell Technician/Pharmacist Susan Carney Cell Technician/Pharmacist Christina Toribio Cell Technician/Pharmacist James Kirkpatrick, MD Echocardiographer
Karen Eberman, Echo Technician
Alfred Ioli Echo Technician
Lise Fishman Manager Echo Lab
Dorothy Kliniewski Data Coordinator
Sally Thompson Contracts Specialist
Steve Mervis Budgets Specialist
University of Southern California Michael Bowdish, MD PI
Vaughn A. Starnes, MD Investigator
David Shavalle, MD Cardiologist
Ray Matthews, MD Cardiologist
Christi Heck, MD Neurologist
Amy Hackmann, MD Cardiac Surgeon
Tracy Lawrence, MD Echocardiologist
Shadi Van Trease, BA, CCRC Coordinator
Edward Lozano Coordinator
Felicia Schenkel Coordinator
Candace Bart, BSN, RN Coordinator
University of Virginia Health System Irving L. Kron, MD PI
Gorav Ailawadi, MD Investigator/ Cardiac Surg.
John Kern, MD Investigator/ Cardiac Surg.
Damien LaPar, MD Investigator/ Cardiac Surg.
Ravi K Ghanta, MD Investigator/ Cardiac Surg.
Karen Johnston, MD Investigator/ Neurologist
Michael Ragosta, MD Cardiologist
Brian Annex, MD Cardiologist
Jim Bergin, MD Cardiologist
Sandra G. Burks, RN, CCRC Coordinator
Kimberly Gahring, RN Coordinator
Jennifer V. Phillips, RN, CCRC Coordinator
Rachel Simon, RN, CCRC Coordinator
10
Cardiothoracic Surgical Trials Network 2014 Participants
Institution Name Role
University of Virginia Health System cont.
John M. Dent, MD Echocardiologist
Dale Fowler Echo Technician
Kim Chadwell Echo Technician
CONSORTIUM CLINICAL CENTERS
Baylor College of Medicine Faisal Bakaeen, MD PI
Cynthia Louise Boudreaux Coordinator
Columbia University Medical Center Michael Argenziano, MD PI
Yoshifumi Naka, MD, PhD Investigator
Mathew R. Williams, MD Investigator
Allan Schwartz, MD Investigator
Martin B. Leon, MD Investigator
Ulrich Peter Jorde, MD Cardiologist
Lyn Goldsmith, MA, RN, BSN, CCRC
Coordinator
Sowmyashree Sreekanth, CCRC Coordinator
Eduardo Marin Coordinator
Hiroo Takayama, MD Investigator Allan Stewart, MD Investigator Rosie Te-Frey, MS, RN LVAD Coordinator
Amanda Alonso Coordinator
Nita Patel Cell Technician/Pharmacist Joseph (Yossi) Schwartz, MD Cell Technician/Pharmacist Shanlong Jiang Cell Technician/Pharmacist Dael Shatrina Cell Technician/Pharmacist Desince Shawn Cell Technician/Pharmacist Sofia Shames, MD Echocardiologist
Leonid (Lenny) Zaurov Echo Technician
Jean Gabeau Contracts Specialist
William Berger Budgets Specialist
Emory University Vinod Thourani, MD PI
Robert Guyton, MD Investigator
Omar Lattouf, MD, PhD Investigator
Edward Chen, MD Investigator
J. David Vega, MD Investigator
Duc Nguyen, MD Investigator
Michael Halkos, MD Investigator
Jefferson Baer, MD, MPH Cardiologist
Kim Baio, RN, MSN Dir. of Research & Education
Alexis Neill, RN, MSN Coordinator
Tamara Prince Coordinator
Dena Manning Coordinator Jayne Danley Thompson RN, CCRC Coordinator
Zachary Pitts Coordinator
Mission Hospital Mark A. Groh, MD PI
Benjamin H. Trichon, MD Cardiologist
Todd H. Hansen, MD Investigator/ Echocardiologist
Tracy Nanney Coordinator
Lynne C. Hampton, MBA, MHA, RN, CCRC, CCRP
Clinical Trials Manager
Ralph Mangusan Coordinator
Leslie E. Shell, BSN, RN, CCRC Coordinator
Stephanie A. Shepard, BSN, RN Coordinator
11
Cardiothoracic Surgical Trials Network 2014 Participants
Institution Name Role
Mission Hospital cont. Mary Richard, RN CPX Lab
Tami R. Young Business Coordinator Susan E. Sutherland, PhD., CHRC Pre-Award and Contracts
Lori Banctel, MPH Pre-Award and Contracts
Mount Sinai Medical Center David H. Adams, MD PI
Robin Varghese, MD Investigator
John Puskas, MD Investigator
Ilja Dejanovic Coordinator
Ohio State University Medical Center
Chittoor Sai-Sudhakar, MBBS PI
Ayseha Hasan, MD Investigator/ Cardiologist
Bryan Whitson, MD Investigator
Asia McDavid, MS Coordinator
Bradley Kinn, BS Coordinator
Christie Hartlev Coordinator
Melinda Cain Coordinator
William T. Abraham, MD Investigator/ Cardiologist
Robert Higgins, MD Investigator
Sherri Wissman LVAD Coordinator
Kelly MacBrair LVAD Coordinator
Anne Knapke LVAD Coordinator
Laura Yamokoski: LVAD Coordinator
Hillary Bradbury MT(ASCP) Manager, Cell Therapy Lab
Lynn O'Donnell, PhD Director, Cell Therapy Lab
Jonathan Kelly Cell Technician/Pharmacist Asia Winterstein Cell Technician/Pharmacist Beth Daneault Cell Technician/Pharmacist Bethany Caudill Cell Technician/Pharmacist Brian Hoelker Data Coordinator
Lynne Miller Regulatory Coordinator
Sandra Sarafin Contract Specialist
St. Vincent Medical Group, Inc. Chris Salerno, MD PI
Minnow Walsh, MD Investigator
Andy Scroggs Coordinator
Toronto General Hospital Terry Yau, MD PI
Michael Farkouh, MD Investigator
Anna Woo, MD Investigator
Robert James Cusimano, MD Investigator
Tirone David, MD Investigator
Christopher Feindel, MD Investigator
Lisa Garrard Coordinator
Suzanne Fredericks RN, PhD Coordinator
Amelia Mociornita Coordinator
Katherine Tsang LVAD Coordinator
University of Alberta John C. Mullen, MD, MSc PI
Harald Becher, MD Cardiologist
Steven Meyer, MD Investigator
Emily Kuurstra Coordinator
University of Maryland James S. Gammie, MD PI
Christopher R. DeFilippi, MD Investigator/ Echocardiologist
Dino T. Gaetani CPX Lab
Robert Villanueva Clinical Research Manager
Dorothy Bryant Coordinator
12
Cardiothoracic Surgical Trials Network 2014 Participants
Institution Name Role
University of Maryland cont. Julia Whinnery Coordinator
Bartley P. Griffith, MD Investigator
Erika Feller, MD Investigator/ Cardiologist
Sunjay Kaushal, MD, PhD Investigator
Lynn Dees, CRNP LVAD Coordinator
Dana Beach, RN Coordinator
Sandy Westphal Cell Technician/Pharmacist Melanie Stierhoff Cell Technician/Pharmacist Sharon Hancock Cell Technician/Pharmacist Gautam Ramani, MD Echocardiologist
Shuying Li Echo Technician
Cindi Young Data Coordinator
Michael Rollor, PhD Contracts Specialist
Ellen Datena, RN, BSN Budgets Specialist
University of Michigan Health Services
Steven Bolling, MD PI
Francis D Pagani, MD Investigator
Cathie Bloem, MPH, RN Coordinator
Nicole Gervais, RN Coordinator
Lydia McGowan LVAD Coordinator
University of Utah Craig Selzman, MD PI
Erin Davis Coordinator
University of Wisconsin Shahab A. Akhter, MD PI
Lauren Godbole Coordinator Nicky Kurtzweil Coordinator Emily Breunig Coordinator Danielle Brezezinski Coordinator Jeffrey Weishaar Coordinator
DATA COORDINATING CENTER
InCHOIR Icahn School of Medicine at Mount Sinai
LEADERSHIP
Annetine C. Gelijns, PhD PI
Michael K. Parides, PhD Investigator
Deborah D. Ascheim, MD Investigator
Alan J. Moskowitz, MD Investigator
Ellen Moquete, RN, BSN Investigator
Eric A. Rose, MD Investigator
Emilia Bagiella, PhD Investigator
Trial Coordination
Kinjal Shah, PA-C Clinical Trial Manager
Anlami Shaw, MBA Clinical Trial Manager
Paula Williams, MS Clinical Trial Manager
James Foo, MAS Sr. Quality Monitor
Cassandra Pineda, MPH Sr. Quality Monitor
Andrea Ratner, RN Sr. Quality Monitor
Gabriela Sanchez-Bravo, BA Quality Monitor
Deborah Williams, BSN, MPH Sr. Clinical Research Associate
Karen O’Sullivan, MPH Clinical Regulatory Manager
Angela Villanueva, MPH, CPH Regulatory Compliance Assoc.
13
Cardiothoracic Surgical Trials Network 2014 Participants
Institution Name Role
DATA COORDINATING CENTER cont.
InCHOIR Icahn School of Medicine at Mount Sinai
Statistics & Data Management
Helena Chang, MS Biostatistician
Jessica Overbey, MS Biostatistician
Katherine Kirkwood, MS Biostatistician
Michael Weglinski, BS, MBA Sr. Programmer/Analyst
Seth D. Goldfarb Data Management
Lopa Gupta, MPH Data Management Analyst
Information Technology
Ron Levitan, DipCompSci Dir. of Information Systems: EDC
Edlira Dobrev, MS Lead Developer for Electronic Data Capture
Xia (Terry) Ye, BS Informatics/ EDC
Administration
Mary Ann Kral, PA-C, MS Chief Operating Officer
Milerva Santos, BS Contract Renewal
Melissa Chase, MPA Executive Assistant
CORE LABS
CARDIOPULMONARY EXERCISE CORE LAB @ Henry Ford Hospital
Steven J. Keteyian, PhD
Clinton A. Brawner, MS, RCEP, FACSM
Heather Aldred, PhD
ECHO CORE LAB @ Massachusetts General Hospital
Hung Judy Hung, MD
Xin Zeng, MD
NEUROCOGNITIVE CORE LAB @ Duke University
Joseph P. Mathew, MD Chief, Division of Cardiothoracic Anesthesiology
Jeff Browndyke, PhD Clinical & Research Neuropsychologist
Yanne Toulgoat-Dubois Clinical Research Coordinator
Rachele Brassard Clinical Research Coordinator ELECTROPHYSIOLOGY CORE LAB @ University of Rochester Medical Center
Jean-Philippe Couderc, PhD Assistant Director of the Heart Research Follow-Up Program
LVAD/MPC BIOSPECIMEN CORE LAB @ Texas Heart Institute
Doris A. Taylor, PhD Director, Biorepository Core Laboratory
Micheline M Resende, PhD Assistant Director, Biorepository Core Laboratory
Deirdre Smith, RN, CCRC Coordinator
Sarah Schneider Coordinator
14
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16
EVALUATION OF OUTCOMES FOLLOWING MITRAL VALVE
REPAIR/REPLACEMENT IN SEVERE CHRONIC ISCHEMIC MITRAL
REGURGITATION
Objectives To evaluate the safety and efficacy of mitral valve repair and mitral valve replacement for patients with severe ischemic mitral regurgitation (MR)
Study Design Randomized multi-center trial Target
Population Patients diagnosed with severe ischemic MR in need of surgical intervention
Rx arms (a) mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering (b) mitral valve replacement and complete preservation of the sub-valvular apparatus
Sample Size 250 subjects; 90% power to detect an absolute difference of 15 ml/m2 in LVESVI (based on a 35% (replacement) v. 20% (repair) reduction in LVESVI)
Duration 24 months following randomization 1 Endpoints Degree of left ventricular remodeling, as assessed by Left Ventricular End Systolic
Volume Index (LVESVI) at 12 months 2 Endpoints o All-cause mortality (Principal secondary endpoint)
o Operative time, cardiopulmonary bypass (CPB) and cross clamp time o Blood loss and transfusion
o MACE (death, stroke, worsening heart failure (+1 NYHA Class), CHF hospitalization, mitral valve re-intervention)
o NYHA Classification and CCSC Angina class o Peak VO2 (assessed by cardio-pulmonary stress test) o LOS for the index hospitalization and discharge location
o Re-admission rates and days alive out of hospital o Echo parameters o Adequacy of revascularization o Change in quality of life (QOL) o Neurocognitive outcomes o Cost and cost effectiveness o Incidence of serious adverse events
o Re-operation for MR and freedom from re-operation in general Selected
Inclusion
Criteria
o Chronic severe ischemic mitral regurgitation by echocardiography using an integrative method
o Eligible for surgical repair and replacement of mitral valve o Coronary artery disease with or without the need for coronary revascularization
Selected
Exclusion
Criteria
o Any evidence of structural mitral valve disease or ruptured papillary muscle o Prior mitral valve repair o Severe pulmonary hypertension o Contraindications to CPB o Inability to derive ERO and ESVI by transthoracic echocardiography o Planned concomitant intra-operative procedures (except closure of PFO, ASD or
Maze procedure) o Clinical signs of cardiogenic shock at the time of randomization o Treatment with chronic intravenous inotropic therapy at the time of
randomization o ST segment elevation MI requiring intervention within 7 days prior to
randomization o Congenital heart disease (except PFO or ASD) o Evidence of cirrhosis or hepatic synthetic failure
17
SURGICAL INTERVENTIONS FOR MODERATE ISCHEMIC
MITRAL REGURGITATION
Objectives To evaluate the safety and efficacy of mitral valve repair for moderate ischemic mitral regurgitation
Study Design Randomized multi-center trial Target Population Patients diagnosed with moderate ischemic MR with a clinical indication for
CABG Rx arms (a) Coronary Artery Bypass Grafting (CABG) + Mitral Valve Repair
(b) CABG Alone Sample Size 300 subjects; 90% power to detect an absolute difference of 12 ml/m2 in LVESVI
(based on a 20% (repair) v. 5% (CABG alone) reduction in LVESVI) Duration 24 months following randomization 1 Endpoints Degree of left ventricular remodeling, as assessed by Left Ventricular End Systolic
Volume Index (LVESVI) at 12 months 2 Endpoints o MACE (death, stroke, worsening heart failure (+1 NYHA Class), CHF
hospitalization, mitral valve [MV] re-intervention); (Principal secondary
endpoint) o All-cause mortality
o NYHA Classification and CCSC Angina class o Peak VO2 (assessed by cardio-pulmonary stress test) o LOS for the index hospitalization and discharge location o Readmission rates & days alive out of hospital o Echo parameters
o Adequacy of revascularization o Change in quality of life (QOL) o Neurocognitive outcomes o Cost and cost effectiveness o Incidence of serious adverse events o Re-operation for MR and freedom from re-operation in general
Selected Inclusion
Criteria
o Moderate mitral regurgitation by echocardiography, using an integrative method
o Coronary artery disease amenable to coronary artery bypass grafting and a clinical indication for revascularization
Selected Exclusion
Criteria
o Any evidence of structural (chordal or leaflet) mitral valve disease o Inability to derive ERO and ESVI by transthoracic echocardiography o Planned concomitant intra-operative procedures (except closure of PFO, ASD,
left atrial appendage ligation/excision or Maze procedure) o Prior surgical or percutaneous mitral valve intervention o Contraindication to cardiopulmonary bypass (CPB) o Clinical signs of cardiogenic shock at the time of randomization o Treatment with chronic intravenous inotropic therapy at the time of
randomization o Severe, irreversible pulmonary hypertension in the judgment of the investigator o ST segment elevation MI requiring intervention within 7 days prior to
randomization o Congenital heart disease (except PFO or ASD) o Evidence of cirrhosis or hepatic synthetic failure
18
SURGICAL ABLATION VERSUS NO SURGICAL ABLATION FOR
PATIENTS WITH PERSISTENT OR LONGSTANDING PERSISTENT
ATRIAL FIBRILLATION UNDERGOING MITRAL VALVE SURGERY
Objectives o To compare the effect of mitral valve surgery (MVS) alone or in combination with atrial fibrillation (AF) ablation on postop heart rhythm in patients with MV disease and persistent or longstanding persistent AF
o Compare 2 different techniques for post-ablation heart rhythm monitoring (long-term monitor at 6 and 12 months vs. weekly rhythm strips) to guide follow-up strategies for future studies of rhythm control in AF patients
o Compare quality of life (QoL) in persistent or longstanding persistent AF patients who undergo surgery for mitral valve disease and receive surgical ablation for AF to those who receive MVS alone
o Obtain preliminary estimates of the relative benefit of pulmonary vein isolation (PVI) alone vs. a biatrial lesion set for ablation in MVS patients
Study Design Randomized controlled trial; patients randomized with equal allocation to MVS alone or to MVS + ablation for AF; patients randomized to MVS + ablation further randomized (1:1) to PVI or ablation with biatrial lesion set.
Target Population Adult patients with persistent or longstanding persistent AF who are undergoing MVS.
Rx arms MVS alone versus MVS + AF ablation Sample Size 260 patients; provides 90% power to detect a 20% difference (25% versus
45%) in freedom from AF (measured at 6 and 12 months) Duration 24 months follow-up following randomization. 1 Endpoints Efficacy: Freedom from AF in patients with mitral valve disease and
persistent or longstanding persistent AF; this will be assessed with 3-day continuous monitoring at 6 and 12 months post-ablation. Safety: Composite of death, stroke, serious AEs (cardiac and non-cardiac), and cardiac re-hospitalizations < 30 days post-procedure or hospital
discharge. 2 Endpoints AF load; freedom from any electrocardiographically documented arrhythmic
recurrence; anti-arrhythmic interventions;; survival (all-cause mortality); safety (i.e., MACE and incidence of protocol-defined and serious adverse events within 12 months after randomization); QoL
3 Endpoints Functional status; hospitalizations; inpatient costs Inclusion Criteria 1. Able to sign Informed Consent and Release of Medical
Information forms 2. Age ≥ 18 years 3. Clinical indications for mitral valve surgery for the following:
Organic mitral valve disease; or Functional non-ischemic mitral regurgitation; or Ischemic mitral regurgitation with evidence of concomitant
structural mitral valve disease Note: May include need for surgical management of functional
tricuspid regurgitation or patent foramen ovale. May also
include concomitant CABG, aortic arch or aortic valve
procedure. Surgical intervention may be performed via
sternotomy or minimally invasive procedure.
19
4. a) Persistent AF within 6 months prior to randomization, defined as non self-terminating AF lasting greater than 7 days, or lasting less than 7 days but necessitating pharmacologic or electrical cardioversion.
Duration of AF must be documented by medical history and Presence of AF must be documented by a direct
electrocardiographic assessment within 6 months prior to randomization.
b) Longstanding persistent AF is defined as continuous AF of greater than one year duration. Duration of AF must be documented by medical history and Presence of AF must be documented by a direct
electrocardiographic assessment upon arrival in the OR. 5. Able to use heart rhythm monitor
Exclusion Criteria 1. AF without indication for mitral valve surgery 2. AF is paroxysmal1 3. Evidence of active infection 4. Mental impairment or other conditions that may not allow
subject to understand the nature, significance, and scope of study 5. Surgical management of hypertrophic obstructive
cardiomyopathy 6. Previous catheter ablation for AF 7. Life expectancy of less than one year 8. Absolute contraindications for anticoagulation therapy 9. Enrollment in concomitant drug or device trials 10. Uncontrolled hypo- or hyperthyroidism 11. FEV1 < 30% of predicted value 12. Women who are pregnant as evidenced by positive pregnancy
test 13. Women of childbearing age who do not agree to be on adequate
birth control throughout the period of the trial. 1Paroxysmal AF is defined as recurrent AF (2 or more episodes) that
terminates spontaneously within 7 days of onset.
20
MANAGEMENT PRACTICES AND THE RISK OF INFECTIONS
FOLLOWING CARDIAC SURGERY
Objectives To identify management practices that put patients at risk for infections post-cardiac surgery. In particular, the specific aims of the study are:
1. To identify modifiable management practices (e.g. surgical site preparation, central line management) and patient characteristics (e.g., diabetes) that are predictive of postoperative infections
2. To delineate management practice variations that may be associated
with higher infection rates among participating clinical centers
3. To assess how major infections, and the management practices associated with their occurrence, affect hospital resource use and inpatient costs
Study Design Multi-center, observational study Target
Population
All patients undergoing cardiac surgical interventions at the 10 Network institutions
Sample Size The sample size is based on the need to observe 200 major infections. Based on literature estimates of infection rates observed in cardiac surgery patients, we estimate that we will need to enroll 3000-4000 patients.
Duration The enrollment period will depend on obtaining the required number of major infections. We estimate a 4-6 month enrollment period but will continue enrollment up to 1 year, as needed. Patients will be followed for 60 day after index cardiac surgical intervention.
1 Endpoints Major infection within 60 days of index cardiac surgical intervention 2 Endpoints o Major infection after surgery occurring during the operative admission
(including readmission for major infection within 30 days after discharge)
o Any other infection (e.g., UTIs) occurring during the operative stay o All-cause mortality o Total number of days alive out-of-hospital o Inpatient costs
Inclusion Criteria o Clinical indication for cardiac surgical interventions o Age ≥ 18 years
Exclusion
Criteria o Active systemic infection at the time of enrollment
21
LVAD THERAPY: EXPLORING THE EFFECT OF
INTRAMYOCARDIAL INJECTION OF MESENCHYMAL PRECURSOR
CELLS ON MYOCARDIAL FUNCTION (LVAD I)
Objectives The primary objective of this exploratory trial is to provide evidence of the safety of direct myocardial injection of a single dose of MPCs in LVAD recipients. The secondary objective is to explore the efficacy of injecting MPCs into the native myocardium of LVAD recipients.
Study Design Prospective, multi-center, double-blind, randomized, single dose cohort, sham procedure controlled trial
Target
Population
Patients with end-stage heart failure, either ischemic or non-ischemic etiology, who are being evaluated for LVAD implantation as a bridge-to-transplant (BTT) or destination therapy (DT)
Rx arms Patients will be enrolled in a single dose cohort randomized in a 2:1 allocation to intramyocardial injection of study product or control (cryoprotective media alone) at the time of LVAD implantation:
o Group 1 (n=20): 25 million MPC (Revascor™) o Group 2 (n=10): 50% Alpha-MEM/42.5% ProFreeze NAO Freezing
Medium/7.5% DMSO (control) Sample Size 30 patients Duration All patients will be followed until cardiac transplantation (for bridge to transplant
patients) or until 12 months post randomization, whichever comes first. 1 Endpoints The primary safety endpoint is the incidence of the following potential study-
intervention related adverse events at 90 days post randomization: o Infectious myocarditis o Myocardial rupture o Neoplasm o Hypersensitivity reaction o Immune sensitization
2 Endpoints o The key efficacy endpoint is functional status and ventricular function, while weaned from LVAD support, at 90 days post randomization.
o Echocardiographic assessments of the myocardial size and function by transthoracic echocardiography with LVAD at full support, and as tolerated at 1and 5 minutes (limited echo) and 15 minutes following initiation of wean, including:
o Left ventricular end-diastolic and end-systolic dimensions; o Left ventricular fractional shortening; o Regional wall motion score index (WMSI) at limited time points only; o RV function (Qualitative: normal, mild, moderate, severe); o RVSP from tricuspid regurgitation (TR) jet; o Global and regional strain from speckle tracking
o 6 Minute walk as tolerated at 20 (± 10) minutes following initiation of wean
o Ability to tolerate wean from LVAD support for 30 minutes without signs and symptoms of hypoperfusion (Note: 90 day time point is the key efficacy endpoint)
o Duration of ability to tolerate wean from LVAD support, without signs and symptoms of hypoperfusion
o Neurocognition at 90 days post randomization
o Incidence of study intervention-related adverse events
o Incidence of all serious adverse events
o Anti-HLA antibody sensitization while on LVAD support o Cardiomyocyte regeneration at explant o Cell Engraftment and Fate at explant o Survival to cardiac transplantation
22
3 Endpoints Phenotypic & functional analyses will be performed on peripheral blood from each subject and on the lot(s) of Revascor™ administered as follows:
o Flow cytometry to phenotype the samples and quantify the following cell populations: Stro1+, CD3, CD11b, CD14, CD19, VEGFR2, CD31, CD34, CD45, CXCR4+, and CD133.
o Functional analysis of the delivered product will be performed using the CFU-F/MSC colony formation assay and of peripheral blood using EPC and MSC assays.
Chemo/cytokine quantification of plasma derived from peripheral blood samples will be performed and include IFN-γ, IFN-α, IP-10, Eotaxin, MIP–1α, MIP-1β, RANTES, TNF–α, MIG, IL–1RA, GM–CSF, IL–1β, IL–2, IL–4, IL–5, IL–6, IL–2R, MCP–1, IL–7, IL–8, IL–10, IL–12 (p40⁄ p70), IL–13, IL–15, IL–17, VEGF, ANG-1, ANG-2, SDF-1, PDGF, and SCF.
Selected
Inclusion
Criteria
1. Admitted to the clinical center at the time of randomization 2. Clinical indication and accepted candidate for implantation of an FDA approved
implantable, non-pulsatile LVAD as a bridge-to-transplant or for destination therapy
Selected
Exclusion
Criteria
1. Planned percutaneous LVAD implantation; 2. Anticipated requirement for biventricular mechanical support; 3. Cardiothoracic surgery within 30 days prior to randomization; 4. Myocardial infarction within 30 days prior to randomization; 5. Prior cardiac transplantation, LV reduction surgery, or cardiomyoplasty 6. Acute reversible cause of heart failure (e.g. myocarditis, profound
hypothyroidism); 7. Stroke within 30 days prior to randomization; 8. Platelet count < 100,000/ul within 24 hours prior to randomization; 9. Active systemic infection within 48 hours prior to randomization; 10. Presence of >10% anti-HLA antibody titers with known specificity to the MPC
donor HLA antigens; 11. A known hypersensitivity to dimethyl sulfoxide (DMSO), murine, and/or
bovine products; 12. History of cancer prior to screening (excluding basal cell carcinoma); 13. Acute or chronic infectious disease, including but not limited to human
immunodeficiency virus (HIV); 14. Received investigational intervention within 30 days of randomization; 15. Treatment and/or an incompleted follow-up treatment of any investigational cell
based therapy within 6 months prior to randomization; 16. Active participation in other research therapy for cardiovascular
repair/regeneration; 17. Prior recipient of stem precursor cell therapy for cardiac repair; 18. Pregnant or breastfeeding at time of randomization.
23
RATE CONTROL VERSUS RHYTHM CONTROL FOR
POSTOPERATIVE ATRIAL FIBRILLATION
Background Postoperative atrial fibrillation is the most common complication following cardiac surgery. Its occurrence is associated with adverse clinical outcomes and increased length of hospital stay and resource utilization. Numerous studies have evaluated strategies for prevention of postoperative atrial fibrillation, though even with the most successful of these approaches, 20% to 25% of adult cardiac surgery patients develop postoperative atrial fibrillation. Data to guide management of surgical patients who develop atrial fibrillation are lacking.
Study Design Randomized (1:1) controlled open-label trial. Patients will be consented prior to surgery and randomized upon occurrence of AF (defined as atrial fibrillation and/or atrial flutter (AFL)) after surgery but during hospitalization to a strategy of either rate or rhythm control.
Sample Size 470 patients Study Objectives To compare the therapeutic strategies of rate versus rhythm control in
cardiac surgery patient who develop in-hospital postoperative AF. Trial Interventions Patients will be randomized to rate or rhythm control. For each therapy,
caregivers will be able to choose from a list of strategies aimed at either rate or rhythm control, depending upon the assigned therapy. Direct current (DC) cardioversion is included in the strategies for rhythm control. Anti-thrombotic medications: Warfarin for patients meeting pre-specified criteria without
contraindications. Aspirin at the discretion of the treating surgeon
Enrollment Inclusion
Criteria Age > 18 years Undergoing heart surgery for coronary artery bypass (on-pump or
off-pump CABG) and/or valve repair or replacement (excluding mechanical valves), including re-operations
Hemodynamically stable Enrollment Exclusion
Criteria LVAD insertion or heart transplantation Maze procedure Trans-apical TAVR History of or planned mechanical valve replacement Correction of complex congenital cardiac defect (excluding bicuspid
aortic valve, atrial septal defect or PFO) History of AF or AFL History of AF or AFL ablation Contraindications to warfarin or amiodarone Need for long-term anticoagulation Concurrent participation in an interventional (drug or device) trial
Randomization Inclusion
Criterion
AF that persists for > 60 minutes or recurrent (more than one) episodes of AF up to 7 days after surgery during the index hospitalization.
1o Endpoint Total number of days in hospital for hospital admissions that occur within
60 days of randomization.
24
2o Endpoints AF- or treatment-related events
Duration of hospital stay from randomization to eligibility for discharge based on AF-related criteria (regardless of whether patient is actually discharged)
Heart rhythm at hospital discharge Heart rhythm (i.e., whether in a stable non-AF rhythm) at 30 and 60
days Time to stable sustained non-AF rhythm < 7 days of randomization
(or hospital discharge, whichever comes first) Need for permanent pacemaker within 60 days of surgery Economic burden Length of stay (LOS) (index hospitalization) LOS (re-hospitalizations, including emergency department (ED)
visits) Outpatient interventions Costs (hospital) as of surgery date Adverse events Mortality Cerebrovascular thromboembolism (stroke, TIA) Non-cerebrovascular thromboembolism Bleeding Selected serious AEs
Ancillary Study Objective To define factors that increase patients’ susceptibility to developing postoperative AF.
25
INTRAMYOCARDIAL INJECTION OF MESENCHYMAL PRECURSOR
CELLS IN LVAD RECIPIENTS (LVAD II)
Objectives The primary objectives of this trial are to evaluate the safety and efficacy of injecting MPCs (150 million dose) into the native myocardium of LVAD recipients. The secondary objectives are to explore the functional and physiologic effects of injecting MPCs (150 million dose) into the native myocardium of LVAD recipients.
Study Design Prospective, multi-center, double-blind, randomized, single dose cohort, sham procedure controlled trial
Target
Population
Patients with end-stage heart failure, either ischemic or non-ischemic etiology, who are being evaluated for LVAD implantation as a bridge-to-transplant (BTT) or destination therapy (DT)
Rx arms Patients will be enrolled in a single dose cohort randomized in a 2:1 allocation to intramyocardial injection of study product or control (cryoprotective media alone) at the time of LVAD implantation:
o Group 1 (n=80): 150 million allogeneic MPCs (Mesoblast, Inc) o Group 2 (n=40): 50% Alpha-MEM/42.5% ProFreeze NAO Freezing
Medium/7.5% DMSO (control) Sample Size 120 patients Duration All patients will be followed until cardiac transplantation (for bridge to transplant
patients) or until 12 months post randomization, whichever comes first. o Myocardial sample donation (at OHT or post mortem as relevant)
1 Endpoints The primary safety endpoint is the incidence of study intervention-related adverse events (i.e., infectious myocarditis, myocardial rupture, neoplasm, hypersensitivity reaction, and immune sensitization). The primary efficacy endpoint is the number of temporary weans from LVAD support tolerated over 12 months following randomization. Weaning schedule: 60 & 90 days, 6, 9 and 12 months (or until transplant, whichever comes first)
2 Endpoints Secondary Endpoints include: Safety
o Incidence of all serious adverse events
o Anti-HLA antibody sensitization while on LVAD support Survival
o Survival to cardiac transplantation Functional Status (at 60 & 90 days, and 6, 9 & 12 months)
o Ability to tolerate wean from LVAD support for 30 minutes; o Duration of ability to tolerate wean from LVAD support o 6 Minute walk as tolerated at 20 (± 10) minutes following initiation of wean
Physiologic Assessments
o Echocardiographic assessments of the myocardial size and function by transthoracic echocardiography with LVAD at full support, and as tolerated following 6 minute walk while weaned from LVAD support
o Myocardial neovascularization at time of explant o Cardiomyocyte regeneration at explant o Cell Engraftment and fate at explant o Anti-HLA sensitization post-transplant (for transplanted BTT patients)
26
Quality of Life & Neurocognition
o Quality of Life (QoL) as assessed by SF12 and Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 & 12 months
o Neurocognition at 90 days and 12 months post randomization
Selected
Inclusion
Criteria
1. Admitted to the clinical center at the time of randomization 2. Clinical indication and accepted candidate for implantation of an FDA approved
implantable, non-pulsatile LVAD as a bridge-to-transplant or for destination therapy
Selected
Exclusion
Criteria
1. Planned percutaneous LVAD implantation; 2. Anticipated requirement for biventricular mechanical support; 3. Cardiothoracic surgery within 30 days prior to randomization; 4. Myocardial infarction within 30 days prior to randomization; 5. Prior cardiac transplantation, LV reduction surgery, or cardiomyoplasty 6. Acute reversible cause of heart failure (e.g. myocarditis, profound
hypothyroidism); 7. Stroke within 30 days prior to randomization; 8. Platelet count < 100,000/ul within 24 hours prior to randomization; 9. Active systemic infection within 48 hours prior to randomization; 10. Presence of >10% anti-HLA antibody titers with known specificity to the MPC
donor HLA antigens; 11. A known hypersensitivity to dimethyl sulfoxide (DMSO), murine, and/or
bovine products; 12. History of cancer prior to screening (excluding basal cell carcinoma); 13. Acute or chronic infectious disease, including but not limited to human
immunodeficiency virus (HIV); 14. Received investigational intervention within 30 days of randomization; 15. Treatment and/or an incomplete follow-up treatment of any investigational cell
based therapy within 6 months prior to randomization; 16. Active participation in other research therapy for cardiovascular
repair/regeneration; 17. Prior recipient of stem precursor cell therapy for cardiac repair; 18. Pregnant or breastfeeding at time of randomization.
27
NEUROPROTECTION WITH AN EMBOLIC PROTECTION DEVICE IN
AVR PATIENTS
Clinical
Significance Periprocedural ischemic neurological injury is prevalent after cardiac surgery
in general and aortic valve replacement (AVR) in particular. Perioperative neurological events significantly increase mortality, morbidity,
and the costs of care. High rates of new neuroradiographic (magnetic resonance imaging [MRI])
lesions following AVR have been found in small studies (32% (Cook et al. 2007)), 47% (Knipp et al. 2005)).
A more recent prospective cohort study (Acker, Messe; n=200) showed clinical strokes in 17% (4% of which were moderate/ severe) and infarct on MRI was seen in 61%. Number (0-34) and volume (16-56000 mm3) of lesions have varied greatly per patient (Messe et al. 2014).
Embolic protection devices have shown to capture emboli, and a recent trial of a novel aortic cannula, which extracts both solid and gaseous emboli by suction, found a significant reduction in both the volume and proportion of patients experiencing new brain lesions.
Objectives The overall objective of this study is to evaluate the safety and efficacy of an embolic protection device to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement. The primary aim of this trial is to evaluate the extent to which the embolic
protection device provides neuroprotection, defined as freedom from acute clinical or radiographic cerebral infarction within 7 days post procedure, in patients undergoing aortic valve surgery.
The secondary aims of this trial are to assess the relationship of neurocognitive, radiographic, and clinical stroke endpoints; and to assess the feasibility of patient enrollment for a confirmatory trial.
Study Design This trial is a randomized trial of an embolic protection device.
Target Population Patients diagnosed with aortic stenosis (AS) with planned AVR Selected Eligibility
Criteria
Inclusion Criteria 1. Age ≥ 65 years 2. Planned and scheduled surgical aortic valve replacement with an approved
valve 3. No evidence of neurological impairment as defined by a NIHSS ≤1 and
modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization Exclusion Criteria
1. History of stroke within 3 months prior to randomization 2. Cardiac catheterization within 7 days of the planned aortic valve replacement 3. Active endocarditis at time of randomization 4. Anticipated inability to tolerate MRI 5. Any other concomitant aortic procedure such as root replacement 6. Concomitant surgical procedures other than CABG 7. Clinical signs of cardiogenic shock or treatment with IV inotropic therapy at
the time of randomization 8. Recent history of psychiatric disease (including drug or alcohol abuse) that is
likely to impair compliance with the study protocol, in the judgment of the investigator
9. Therapy with an investigational intervention
28
Rx arms Patients will be enrolled in a 1:1 allocation to one of the following: a) Use of embolic protection device b) Standard aortic cannula
10 Endpoint The primary efficacy endpoint is freedom from stroke as defined by the American
Heart Association (ie, clinical or radiographic CNS infarction) at 7 days post procedure.
20 Endpoints Composite Clinical Endpoint
o A composite endpoint of mortality and thromboembolic events (including clinical stroke and acute kidney injury) within 90 days of surgery
Safety
o Serious adverse events within 90 days of surgery Emboli Captured
o Average number of emboli captured and surface area
o Histological characteristics
Clinical and Radiographic Brain Injury
o Number of patients with clinical stroke within 7 days post procedure o Volume of acute ischemic brain lesions assessed by DWI at 7 days post
procedure o Number of acute ischemic brain lesions assessed by DWI at 7 days post
procedure Functional Status and Neurocognition
o Neurocognitive function in 6 domains (memory, information processing speed, executive function, language, attention, and visuospatial/constructional) assessed pre-operatively and at 90 days post procedure
o Neurological outcomes assessed by NIHSS pre-operatively and at 3, 7, 30, and 90 days; and assessed by the mRS and Barthel Index pre-operatively and at 30 and 90 days post procedure
Survival
o All-cause mortality Hospitalization (≤ 90 days)
o LOS of index hospitalization (including ICU days) o Number and reasons for readmissions o Days alive out of the hospital
Economic o Hospital resource utilization ≤ 90 days
Sample size N=300 Data and Safety
Monitoring
An independent Data and Safety Monitoring Board (DSMB) will oversee patient safety and overall progress of the study. A Data Coordinating Center (DCC) internal clinician reviewer and an independent medical monitor will review the safety data and will provide information to the DSMB Chair in the interval between DSMB meetings. An independent Event Adjudication Committee (EAC) will review and adjudicate adverse events occurring during this trial. Stopping guidelines for safety will be developed based upon trial data.
Duration Accrual will take 18 months, and all patients will be followed for 90 days following surgery
29
RANDOMIZED TRIAL OF FFR-GUIDED CORONARY
REVASCULARIZATION
Objectives The primary objective of this trial is to assess feasibility of conducting a larger, confirmatory trial of functionally (fractional flow reserve [FFR]) versus angiography guided coronary artery bypass grafting (CABG). The secondary objectives are to estimate the probability that FFR guided CABG is associated with different Major Adverse Coronary and Cerebrovascular Events (MACCE) outcomes than angiography guided FFR, as a basis for a “go/no go” decision for a larger confirmatory trial; and to examine differences in other important secondary outcomes including ventricular wall motion and left ventricular function, graft patency, graft placement, surgical complications, health resource utilization, neurocognitive measures, angina, and quality of life.
Study Design Prospective, multi-center, randomized feasibility trial Target Population Patients with multi-vessel coronary artery disease and a clinical indication for
CABG surgery Rx arms o FFR-guided CABG
o Angiography-guided CABG Sample Size 400 patients Duration All patients will be followed for at least 12 months following randomization 1 Endpoints The primary endpoint is MACCE (all-cause mortality, repeat revascularization,
stroke, myocardial infarction) over 12 months 2 Endpoints Secondary Endpoints include:
Anatomic/Physiologic
o Regional wall motion: Change from baseline of all vascular territories (Echo)
o LV function: Change from baseline (pre- and post-op EF) o Non-LAD graft failure at 12 months (Cardiac Computed Tomography
Angiography [CCTA]) o LAD graft failure at 12 months (CCTA) o Native coronary artery patency at 1 year (CCTA)
Clinical
o Individual components of MACCE at 12 & 24 months and time to event o MACCE over 24 months o Incidence of serious adverse events o Neurocognitive outcomes at 12 months
Quality of Life
o Angina (Seattle Angina Questionnaire) o Overall Quality of Life (QOL) measure (SF12, EuroQOL)
Health Resource Utilization
o Resource utilization during index hospitalization: overall length of stay (LOS), post-operative LOS, intensive care unit (ICU) LOS, operating room (OR) time
o Readmissions o Health-care related costs
30
Selected Inclusion
Criteria
1. Age ≥ 18 years 2. CAD requiring CABG with planned multi-vessel bypass grafting to include
internal mammary artery (IMA) graft to LAD based on standard angiographic and clinical criteria
3. ≥ One vessel 30-90% stenosis by angiography not including left main or proximal LAD stenoses
4. FFR/angiography discordance in an left circumflex (LCx) and/or right coronary artery (RCA) lesion(s) as determined by the FFR-Unblinded Site Cardiologist; discordance is defined as FFR negative (> 0.8) and 50-90% stenosis by angiography, or FFR positive (≤ 0.8) lesion and 30-49% stenosis by angiography
5. Participant willing to undergo CABG surgery and comply with the protocol 6. Signed informed consent, inclusive of release of medical information, and
Health Insurance Portability and Accountability Act (HIPAA) documentation
Selected Exclusion
Criteria
1. Patients whose surgical revascularization plan would not differ based on angiographic and FFR criteria
2. Contraindication to CABG surgery 3. Previous CABG surgery 4. Complex congenital heart disease 5. Indication for a major concomitant cardiac or vascular surgical procedure 6. STEMI within 5 days prior to screening3 7. Non-STEMI with peak CK>1000 IU1 within 5 days prior to screening 8. LVEF < 35% within 3 months prior to screening 9. Severe LVH within 3 months prior to screening*5 10. Cardiogenic shock requiring pharmacologic inotropic or mechanical support
at time of screening 11. Inability to undergo CCTA with iodinated contrast 12. Moderate to Severe CKD (eGFR<60) at time of screening 13. Life expectancy < 2 years 14. Participation in another clinical trial involving an investigational drug or
device at time of screening 15. Pregnant at time of screening
31
Clinical Site Participation (in order of initiation)
Site Name Participating Protocols
SMR MMR AF Infx LVAD I POAF LVAD II
Cleveland Clinic Foundation X X X X X X X
Columbia Univ. Medical Center X X X X X X X
Duke University X X X X X X X
East Carolina Heart Institute X X X X
Emory University X X X X X
Montefiore-Einstein Heart Center X X X X X X X
Montreal Heart Institute X X X X X
Sacre-Coeur de Montreal X X X
CHUM X X NIH Heart Ctr @ Suburban Hospital X X X X X
University of Pennsylvania X X X X X X X Univ. of Virginia Health System X X X X X X Inova Heart & Vascular Inst. X X
Hopital Laval X X X X X
Ohio State Univ. Medical Center X X X X X X
WellStar I Kennestone X X
Baylor
Research
Institute
Heart Hospital Plano X X X
X
X X
X X
Vascular Institute
Medical City Dallas
Mission Hospital X X X
University of Maryland X X X X X X
University of Southern California X X X X
Washington University X X
Brigham and Women's Hospital X X X
Christiana Care X
Lankenau X X
University of Chicago X
University of Michigan X X X
Baystate Medical Center X X
University of Alberta X X X X
Yale New Haven X
Mount Sinai Medical Center X X
Toronto General Hospital X X X
St. Michael's Hospital X Sunnybrook Health Sciences Centre X
Jewish Hospital X
Aarhus University X
Baylor College of Medicine X
University of Wisconsin X X
St. Vincent’s Indianapolis X
University of Utah X
CCTRN Sites University of Florida X Minneapolis Heart Institute X University of Minnesota X Sharp Memorial X Texas Heart Institute X
32
SELECTED PUBLICATIONS
Gardner TJ, O’Gara PT. The Cardiothoracic Surgery Network: randomized clinical trials in the operating room. J Thorac Cardiovasc Surg. 2010 Apr;139(4):830-834. PMCID (requested) PMID:20304133
Gillinov AM, Argenziano M, Blackstone EH, Iribarne A, DeRose JJ Jr, Ailawadi G, Russo MJ, Ascheim DD, Parides MK, Rodriguez E, Bouchard D, Taddei-Peters WC, Geller NL, Acker MA, Gelijns AC. Designing comparative effectiveness trials of surgical ablation for atrial fibrillation: experience of the Cardiothoracic Surgical Trials Network. J Thorac Cardiovasc Surg. 2011 Aug;142(2):257-64.e2. NIHMSID: NIHMS450781 PMID:21616507
Gardner TJ, Miller MA, O'Gara PT, Gelijns AC. Building an infrastructure for clinical trials in cardiac surgery. J Thorac Cardiovasc Surg. 2011 Aug;142(2):265-6. PMCID (requested) PMID:21763873 Smith PK, Michler RE, Woo YJ, Alexander JH, Puskas JD, D’Alessandro DA, Hahn RT, Williams JB, Dent JM, Ferguson TB, Moquete E, Pagé P, Jeffries NO, O’Gara PT, Ascheim DD. Design, Rationale, and Initiation of the Surgical Interventions for Moderate Ischemic Mitral Regurgitation Trial: A Report from the Cardiothoracic Surgical Trials Network. J Thorac Cardiovasc Surg. 2012 Jan;143(1):111-117.e1. NIHMSID: NIHMS299593 PMID:21788032 Perrault LP, Moskowitz AJ, Kron IL, Acker MA, Miller MA, Horvath KA, Thourani VH, Argenziano M, D'Alessandro DA, Blackstone EH, Moy CS, Mathew JP, Hung J, Gardner TJ, Parides MK. Optimal surgical management of severe ischemic mitral regurgitation: To repair or to replace? J Thorac Cardiovasc Surg. 2012 Jun;143(6):1396-403. NIHMSID: NIHMS450782 PMID:22054660 Tong BC, Huber JC, Ascheim DD, Puskas JD, Ferguson TB, Blackstone EH, Smith PK. Composite Endpoints in Clinical Trials: Essential Evidence for the Heart Team. Ann Thorac Surg. 2012 Dec;94(6):1908-13. PMCID: PMC3751408 Horvath KA, Acker MA, Chang H, Bagiella E, Smith PK, Iribarne A, Kron IL, Lackner P, Argenziano M, Ascheim DD, Michler RE, Van Patten D, Puskas JD, O’Sullivan K, Kliniewski D, Jeffries NO, O’Gara, PT, Moskowitz AJ, Blackstone EH. Blood Transfusion and Infection After Cardiac Surgery. Ann Thorac Surg. 2013 Jun;95(6):2194-201. NIHMSID: NIHMS557539 PMID:23647857
Acker MA, Parides MK, Perrault LP, Moskowitz AJ, Gelijns AC, Voisine P, Smith PK, Hung JW, Blackstone EH, Puskas JD, Argenziano M, Gammie JS, Mack M, Ascheim DD, Bagiella E, Moquete EG, Ferguson TB, Horvath KA, Geller NL, Miller MA, Woo YJ, D'Alessandro DA, Ailawadi G, Dagenais F, Gardner TJ, O'Gara PT, Michler RE, Kron IL; for the CTSN Investigators. Mitral-Valve Repair versus Replacement for Severe Ischemic Mitral Regurgitation. N Engl J Med. 2014 Jan 2;370(1):23-32. PMID:24245543
33
Xin Zeng, Maria Carmo P. Nunes, John Dent, Linda Gillam, Joseph P. Mathew, James S. Gammie, Deborah D. Ascheim, Ellen Moquete, Judy Hung. Asymmetric versus Symmetric Tethering Patterns in Ischemic Mitral Regurgitation: Geometric Differences from Three-Dimensional Transesophageal Echocardiography. J Am Soc Echo. April 2014;27(4):367-75. DD Ascheim, AC Gelijns, D Goldstein, LA Moye, N Smedira, S Lee, CT Klodell, A Szady, MK Parides, N Jeffries, D Skerrett, DA Taylor, JE Rame, C Milano, JG Rogers, J Lynch, T Dewey, E Eichhorn, B Sun, D Feldman, R Simari, PT O’Gara, W Taddei-Peters, MA Miller, Y Naka, E Bagiella, EA Rose, YJ Woo. Mesenchymal Precursor Cells as Adjunctive Therapy in Recipients of Contemporary LVADs. Circulation. 2014 Mar 28; epub ahead of print. Gelijns AC, Moskowitz AJ, Acker MA, Argenziano M, Geller NL, Puskas JD, Perrault LP, Smith PK, Kron IL, Michler RE, Miller MA, Gardner TJ, Ascheim DD, Lackner P, Goldsmith LA, Robichaud S, Miller RA, Rose EA, Ferguson, Jr. TB, Horvath KA, Moquete EG, Parides MK, Bagiella E, O’Gara PT, Blackstone EH, For the Cardiothoracic Surgical Trials Network (CTSN). Management Practices and Major Infections After Cardiac Surgery. (JACC accepted 4/10/14) Giampaolo Greco, Wei Shi, Robert E. Michler, David O. Meltzer, Gorav Ailawadi, Samuel F. Hohmann, Vinod Thourani, Michael Argenziano, John Alexander, Kathy Sankovic, Lopa Gupta, Eugene H. Blackstone, Michael A. Acker, Mark J. Russo, Albert Lee, Sandra G. Burks, Annetine C. Gelijns, Emilia Bagiella, Alan J. Moskowitz, Timothy J. Gardner. Costs Associated with Healthcare-Associated Infections in Cardiac Surgery. (JACC under review)
Alexander Iribarne, Helena Chang, John H. Alexander, A. Marc Gillinov, Ellen Moquete, John D. Puskas, Emilia Bagiella, Mary Lou Mayer, T. Bruce Ferguson, Sandra Burks, Louis P. Perrault, Stacey Welsh, Karen Johnston, Mandy Murphy, Joseph J. DeRose, Alexis Neill, Edlira Dobrev, Kim T. Baio, Wendy Taddei-Peters, Alan J. Moskowitz, Patrick T. O'Gara. Readmissions After Cardiac Surgery: Experience of the NIH / CIHR Cardiothoracic Surgical Trials Network. (Ann Thorac Surg. resubmitted) Irving Kron, Judy Hung, Jessica Overbey, Denis Bouchard, Annetine Gelijns, Alan J. Moskowitz, Pierre Voisine, Patrick T. O’Gara, Michael Argenziano, Robert Michler, A. Marc Gillinov, John Puskas, James Gammie, Michael Mack, Peter K. Smith, Chittoor Sai-Sudhakar, Timothy J. Gardner, Gorav Ailawadi, Xin Zeng, Karen O’Sullivan, Michael K. Parides, Roger Swayze, Vinod Thourani, Eric A. Rose, Louis P. Perrault, Michael Acker. Predicting Recurrent MR Following MV Repair for Severe Ischemic MR: Insights from the CTSN Severe IMR Trial. (J Thorac Cardiovasc Surg under review)
34
CTSN In-Person Investigator Meeting Attendees
Tuesday, May 20, 2014 Meeting: 10:00 AM – 3:00 PM
Renaissance Arlington Capital View Hotel 2800 South Potomac Avenue, Arlington, VA 22202
First Name Last Name Institution Role
1. Timothy Gardner Christiana Care Health System CTSN Chair
2. Patrick O’Gara Brigham & Women's Hospital CTSN Co-Chair
CLINICAL CENTERS
3. Michael Mack Baylor Research Institute PI
4. Robert L. Smith Baylor Research Institute Investigator
5. Gonzalo Gonzalez Baylor Research Institute Investigator
6. Tracy Adame Baylor Research Institute Coordinator
7. Kristin Kirtland Baylor Research Institute Coordinator
8. Alice Kruger Baylor Research Institute Coordinator
9. Melissa Johnson Baylor Research Institute Coordinator
10. Bruce Lytle Cleveland Clinic Foundation PI
11. Marc Gillinov Cleveland Clinic Foundation Investigator
12. Kristen Doud Cleveland Clinic Foundation Coordinator
13. Carrie Geither Cleveland Clinic Foundation Coordinator
14. Michelle Garcia Cleveland Clinic Foundation Coordinator
15. Peter Smith Duke University PI
16. John Alexander Duke University Investigator
17. Brian Gulack Duke University NIH Scholar
18. Stacey Welsh Duke University Coordinator
19. Pierre Voisine Laval Hospital, Quebec PI
20. Francois Dagenais Laval Hospital, Quebec Investigator
21. Gladys Dussault Laval Hospital, Quebec Coordinator
22. Hugo Tremblay Laval Hospital, Quebec Coordinator
23. Patricia Landry Laval Hospital, Quebec Coordinator
24. Robert Michler Montefiore-Einstein Heart Center PI
25. David D’Alessandro Montefiore-Einstein Heart Center Investigator 26. Joseph DeRose Montefiore-Einstein Heart Center Investigator 27. Roger Swayze Montefiore-Einstein Heart Center Coordinator
28. Nadia Sookraj Montefiore-Einstein Heart Center Coordinator
29. Juan Garcia Montefiore-Einstein Heart Center Coordinator
30. Rebecca Meli Montefiore-Einstein Heart Center Coordinator
31. Louis Perrault Montreal Heart Institute PI
32. Keith Horvath NIH Suburban Hospital PI
33. Mandy Murphy NIH Suburban Hospital Coordinator
34. Michael Acker University of Pennsylvania PI
35. Pavan Atluri University of Pennsylvania Investigator
36. Steven Messe University of Pennsylvania Investigator
37. Mary Lou Mayer University of Pennsylvania Coordinator
38. Katie Tremont University of Pennsylvania Coordinator
39. Stephen Creese University of Pennsylvania Coordinator
40. Michael Bowdish University of Southern California PI
41. Christi Heck University of Southern California Neurologist
42. David Shavelle University of Southern California Cardiologist
43. Amy Hackmann University of Southern California Cardiac Surg.
44. Tracy Lawrence University of Southern California Echo Cardiologist
45. Edward Lozano University of Southern California Coordinator
46. Shadi Van Trease University of Southern California Coordinator
47. Felicia Schenkel University of Southern California Coordinator
48. Irving Kron University of Virginia Health System PI
49. Gorav Ailawadi University of Virginia Health System Cardiac Surg.
50. John Kern University of Virginia Health System Cardiac Surg.
51. Damien LaPar University of Virginia Health System Investigator
52. Karen Johnston University of Virginia Health System Neurologist
53. Sandra Burks University of Virginia Health System Coordinator
35
First Name Last Name Institution Role
CONSORTIUM SITES
54. Faisal Bakaeen Baylor College of Medicine PI
55. Nicolas Noiseux Centre Hospitalier de l'Université de Montréal
PI
56. Michael Argenziano Columbia University Medical Center PI
57. Sowmya Sreekanth Columbia University Medical Center Coordinator
58. Vinod Thourani Emory University PI
59. Tamara Prince Emory University Coordinator
60. Ralph Mangusan Mission Hospital Coordinator
61. Robin Varghese Mount Sinai Medical Center Investigator
62. Ilja Dejanovic Mount Sinai Medical Center Coordinator
63. John Puskas Mount Sinai Medical Center Investigator
64. Sai Sudhakar Ohio State University Medical Center PI
65. Bryan Whitson Ohio State University Medical Center Investigator
66. Asia McDavid Ohio State University Medical Center Coordinator
67. Hugues Jeanmart Sacré-Coeur, Montreal PI
68. Minnow Walsh St. Vincent Medical Group, Inc. Investigator
69. Terry Yau Toronto General Hospital PI
70. Lisa Garrard Toronto General Hospital Coordinator
71. Katherine Tsang Toronto General Hospital Coordinator
72. John Mullen University of Alberta PI
73. Emily Kuurstra University of Alberta Coordinator
74. James Gammie University of Maryland PI
75. Julia Whinnery University of Maryland Coordinator
76. Robert Villanueva University of Maryland Clinical Research Mgr
77. Steven Bolling University of Michigan Health Services PI
78. Lydia McGowan University of Michigan Health Services Coordinator
79. Craig Selzman University of Utah PI
80. Erin Davis University of Utah Coordinator
81. Shahab Akhter University of Wisconsin PI
82. Jeffrey Weishaar University of Wisconsin Coordinator
NIH and CIHR
83. Marissa Miller NHLBI Program Director
84. Wendy Taddei-Peters NHLBI Regulatory Expert
85. Albert Lee NHLBI Deputy Program Director
86. Amy Connolly NHLBI Senior Grants Management Specialist
87. Nancy Geller NHLBI Director, Office of Biostatistics Research
88. Neal Jeffries NHLBI Office of Biostatistics Research
89. Claudia Moy NINDS Program Director
90. Ilana Gombos CIHR Assistant Director
DATA COORDINATING CENTER
91. Annetine Gelijns InCHOIR MSSM PI
92. Eric Rose InCHOIR MSSM Investigator
93. Mary Ann Kral InCHOIR MSSM COO
94. Deborah Ascheim InCHOIR MSSM Investigator
95. Ellen Moquete InCHOIR MSSM Investigator 96. Michael Parides InCHOIR MSSM Investigator 97. Emilia Bagiella InCHOIR MSSM Investigator 98. Melissa Chase InCHOIR MSSM Executive Assistant
99. Paula Williams InCHOIR MSSM Clinical Trial Manager
100. Deborah Williams InCHOIR MSSM Sr. Clin. Research Assoc.
101. Kinjal Shah InCHOIR MSSM Clinical Trial Manager
102. Lopa Gupta InCHOIR MSSM Data Mgt. Analyst
103. Angela Villanueva InCHOIR MSSM Regulatory Compliance
36
First Name Last Name Institution Role
104. Gabriela Sanchez-Bravo InCHOIR MSSM Quality Monitor
105. James Foo InCHOIR MSSM Sr. Quality Monitor
106. Cassandra Pineda InCHOIR MSSM Sr. Quality Monitor
107. Anlami Shaw InCHOIR MSSM Clinical Trial Manager
108. Helena Chang InCHOIR MSSM Biostatistician
109. Jessica Overbey InCHOIR MSSM Biostatistician
110. Katie Kirkwood InCHOIR MSSM Biostatistician
111. Seth Goldfarb InCHOIR MSSM Data Management
CORE LABS
112. Judy Hung Massachusetts General Hospital Echo Core Lab
113. Jeffrey Browndyke Duke University Neurocog Core Lab
37
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www.ctsurgerynet.org
DCC • InCHOIR • New York, NY
