Assessment of Combined CCM and ICD Device in HFrEF
Public ClinicalTrials.gov record NCT05855135. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05855135
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 300 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 17, 2023 (Actual)
- Primary completion
- May 2026 (Estimated)
- Completion
- Jul 2027 (Estimated)
- Last update posted
- May 27, 2026
2023 – 2027
United States locations
- U.S. sites
- 59
- U.S. states
- 21
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Heart | Glendale | Arizona | 85306 | — |
| CardioVascular Associates of Mesa | Mesa | Arizona | 85206 | — |
| Southwest Cardiovascular Associates | Mesa | Arizona | 85208 | — |
| Arizona Heart Rhythm | Phoenix | Arizona | 85016 | — |
| CVC Cardiovascular Consultants | Phoenix | Arizona | 85032 | — |
| Phoenix Heart | Phoenix | Arizona | 85306 | — |
| Honor Health | Scottsdale | Arizona | 85258 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| Hartford HealthCare | Hartford | Connecticut | 06102 | — |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | — |
| Baptist Health South Florida | Miami | Florida | 33173 | — |
| Mount Sinai Medical Center Miami Beach | Miami Beach | Florida | 33140 | — |
| Advent Health Orlando | Orlando | Florida | 32803 | — |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66103 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | — |
| St. Louis VA | St Louis | Missouri | 63106 | — |
| St. Louis Heart and Vascular | St Louis | Missouri | 63136 | — |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | — |
| Virtua | Cherry Hill | New Jersey | 08034 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| The Heart House - Cardiovascular Associates of the Delaware Valley | Haddon Heights | New Jersey | 08035 | — |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | — |
| NYU Langone | New York | New York | 10016 | — |
| Mount Sinai New York | New York | New York | 10029 | — |
| Columbia University Medical Center / NewYork-Presbyterian | New York | New York | 10032 | — |
| Weill Cornell Medicine | New York | New York | 10065 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Sanger Heart and Vascular Institute | Charlotte | North Carolina | 28277 | — |
| Louis Stokes Cleveland VA Medical Center | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| St. Francis Tulsa | Tulsa | Oklahoma | 74136 | — |
| Portland VA Medical Center | Portland | Oregon | 97239 | — |
| St. Luke's Bethlehem | Bethlehem | Pennsylvania | 18015 | — |
| Bryn Mawr Medical Specialists Association | Bryn Mawr | Pennsylvania | 19010 | — |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17602 | — |
| Penn Presbyterian | Philadelphia | Pennsylvania | 19104 | — |
| Temple University | Philadelphia | Pennsylvania | 19140 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15219 | — |
| Prisma Health | Greenville | South Carolina | 29601 | — |
| Stern Cardiovascular Foundation | Germantown | Tennessee | 38138 | — |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | — |
| Medical City Dallas | Dallas | Texas | 75230 | — |
| UT Southwestern | Dallas | Texas | 75390 | — |
| Medical City Fort Worth | Fort Worth | Texas | 76104 | — |
| Houston Methodist | Houston | Texas | 77030 | — |
| Houston VA Hospital | Houston | Texas | 77030 | — |
| UT Memorial Hermann | Houston | Texas | 77030 | — |
| Christus Trinity Clinic | Tyler | Texas | 75702 | — |
| Centra Health | Lynchburg | Virginia | 24501 | — |
| Chippenham Hospital | Richmond | Virginia | 23225 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
| Seattle VA | Seattle | Washington | 98108 | — |
| Swedish | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05855135, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 27, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05855135 live on ClinicalTrials.gov.