300
Participants
Start Date
May 17, 2023
Primary Completion Date
January 31, 2026
Study Completion Date
July 31, 2027
OPTIMIZER® Integra CCM-D System (Treatment Arm)
"The CCM-D System is an implantable cardiac device system that combines cardiac contractility modulation and implantable cardioverter defibrillator (ICD) modules into one device. CCM-D is also known as a Cardiac Contractility Modulation - Defibrillator. All 300 subjects will be implanted with the CCM-D System and followed for a period of at least two years."
NYU Langone, New York
Mount Sinai New York, New York
Columbia University Medical Center / NewYork-Presbyterian, New York
Weill Cornell Medicine, New York
Allegheny General Hospital, Pittsburgh
University of Pittsburgh Medical Center, Pittsburgh
Lancaster General Hospital, Lancaster
St. Luke's Bethlehem, Bethlehem
Bryn Mawr Medical Specialists Association, Bryn Mawr
Penn Presbyterian, Philadelphia
Temple University, Philadelphia
Chippenham Hospital, Richmond
Virginia Commonwealth University, Richmond
Centra Health, Lynchburg
University of North Carolina, Chapel Hill
Sanger Heart and Vascular Institute, Charlotte
Prisma Health, Greenville
Advent Health Orlando, Orlando
Mount Sinai Medical Center Miami Beach, Miami Beach
Baptist Health South Florida, Miami
Broward Health Medical Center, Fort Lauderdale
Cleveland Clinic Weston, Weston
Stern Cardiovascular Foundation, Germantown
Baptist Health Lexington, Lexington
The Ohio State University Wexner Medical Center, Columbus
Cleveland Clinic, Cleveland
Iowa Heart Center, West Des Moines
St. Louis VA, St Louis
St. Louis Heart and Vascular, St Louis
Saint Luke's Hospital, Kansas City
University of Kansas Medical Center, Kansas City
St. Francis Tulsa, Tulsa
Medical City Dallas, Dallas
UT Southwestern, Dallas
Christus Trinity Clinic, Tyler
Medical City Fort Worth, Fort Worth
Houston Methodist, Houston
Houston VA Hospital, Houston
Texas Cardiac Arrhythmia Research Foundation, Austin
Aurora Denver Cardiology Associates, Aurora
Arizona Heart Rhythm, Phoenix
CVC Cardiovascular Consultants, Phoenix
CardioVascular Associates of Mesa, Mesa
Southwest Cardiovascular Associates, Mesa
Honor Health, Scottsdale
Phoenix Heart, Glendale
Phoenix Heart, Phoenix
University of Southern California, Los Angeles
Cedars Sinai Medical Center, Los Angeles
Portland VA Medical Center, Portland
Seattle VA, Seattle
Swedish, Seattle
Hartford HealthCare, Hartford
Massachusetts General Hospital, Boston
Deborah Heart and Lung Center, Browns Mills
Virtua, Cherry Hill
Hackensack University Medical Center, Hackensack
The Heart House - Cardiovascular Associates of the Delaware Valley, Haddon Heights
Rutgers New Jersey Medical School, Newark
Lead Sponsor
Impulse Dynamics
INDUSTRY