ClinicalTrials.gov record
Assessment of Combined CCM and ICD Device in HFrEF
ClinicalTrials.gov ID: NCT05855135
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.
ClinicalTrials.gov public records Last synced Apr 20, 2026, 7:29 AM EDT
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
Study identification
- NCT ID
- NCT05855135
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- Impulse Dynamics
- Industry
- Enrollment
- 300 participants
Conditions and interventions
Conditions
Interventions
- OPTIMIZER® Integra CCM-D System (Treatment Arm) Device
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 16, 2023
- Primary completion
- Dec 31, 2025
- Completion
- Jun 30, 2027
- Last update posted
- Jul 30, 2025
2023 – 2027
United States locations
- U.S. sites
- 59
- U.S. states
- 22
- U.S. cities
- 45
| 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 | — |
| Aurora Denver Cardiology Associates | Aurora | Colorado | 80012 | — |
| 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 | — |
| Cleveland Clinic Weston | Weston | Florida | 33331 | — |
| 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 | — |
| 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 | — |
| 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 Jul 30, 2025 · Synced Apr 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05855135 live on ClinicalTrials.gov.