Assessment of Combined CCM and ICD Device in HFrEF
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective) — Implant
Evaluate the device effectiveness in converting induced VF at the time of implantation. - Device-related Complications (Primary Safety Objective) — Implant to 6 months
Evaluate device-related complications through 6-months (excluding lead-related complications).
Trial sites (59)
| 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.
More Impulse Dynamics trials in the USA
Other trials for the same condition
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