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.
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%).
Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.
| Facility | City | Region | Status |
|---|---|---|---|
| Phoenix Heart | Glendale | Arizona | |
| CardioVascular Associates of Mesa | Mesa | Arizona | |
| Southwest Cardiovascular Associates | Mesa | Arizona | |
| Arizona Heart Rhythm | Phoenix | Arizona | |
| CVC Cardiovascular Consultants | Phoenix | Arizona | |
| Phoenix Heart | Phoenix | Arizona | |
| Honor Health | Scottsdale | Arizona | |
| University of Southern California | Los Angeles | California | |
| Cedars Sinai Medical Center | Los Angeles | California | |
| Hartford HealthCare | Hartford | Connecticut | |
| Broward Health Medical Center | Fort Lauderdale | Florida | |
| Baptist Health South Florida | Miami | Florida | |
| Mount Sinai Medical Center Miami Beach | Miami Beach | Florida | |
| Advent Health Orlando | Orlando | Florida | |
| Iowa Heart Center | West Des Moines | Iowa | |
| University of Kansas Medical Center | Kansas City | Kansas | |
| Baptist Health Lexington | Lexington | Kentucky | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Saint Luke's Hospital | Kansas City | Missouri | |
| St. Louis VA | St Louis | Missouri | |
| St. Louis Heart and Vascular | St Louis | Missouri | |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | |
| Virtua | Cherry Hill | New Jersey | |
| Hackensack University Medical Center | Hackensack | New Jersey | |
| The Heart House - Cardiovascular Associates of the Delaware Valley | Haddon Heights | New Jersey | |
| Rutgers New Jersey Medical School | Newark | New Jersey | |
| NYU Langone | New York | New York | |
| Mount Sinai New York | New York | New York | |
| Columbia University Medical Center / NewYork-Presbyterian | New York | New York | |
| Weill Cornell Medicine | New York | New York | |
| University of North Carolina | Chapel Hill | North Carolina | |
| Sanger Heart and Vascular Institute | Charlotte | North Carolina | |
| Louis Stokes Cleveland VA Medical Center | Cleveland | Ohio | |
| Cleveland Clinic | Cleveland | Ohio | |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | |
| St. Francis Tulsa | Tulsa | Oklahoma | |
| Portland VA Medical Center | Portland | Oregon | |
| St. Luke's Bethlehem | Bethlehem | Pennsylvania | |
| Bryn Mawr Medical Specialists Association | Bryn Mawr | Pennsylvania | |
| Lancaster General Hospital | Lancaster | Pennsylvania |
+ 19 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05855135 on ClinicalTrials.gov ↗ ← All trials in the USA