Assessment of Combined CCM and ICD Device in HFrEF (NCT05855135)
Assessment of the Safety and Efficacy of a Combined Cardiac Contractility Modulation and Implantable Cardioverter Defibrillator Device for Subjects With Heart Failure and Reduced Ejection Fraction
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Phoenix Heart — Glendale, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (59 Sites)
Showing the first 25 of 59 sites.
- 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
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.