Clinical trial
Assessment of Combined CCM and ICD Device in HFrEF
NCT05855135 · Impulse Dynamics, Industry · Active, not recruiting
Key facts
| NCT number | NCT05855135 |
|---|---|
| Title | Assessment of Combined CCM and ICD Device in HFrEF |
| 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 |
| Acronym | INTEGRA-D |
| Lead sponsor | Impulse Dynamics, Industry |
| Status | Active, not recruiting |
| Study type | Interventional |
| Conditions | Heart Failure, Heart Failure With Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy, Non-ischemic Cardiomyopathy, Ischemic Cardiomyopathy, Sudden Cardiac Arrest, Arrhythmias, Cardiac, Ventricular Tachycardia and 1 more |
| Intervention type | Device |
| Interventions | OPTIMIZER® Integra CCM-D System (Treatment Arm) |
| Enrollment | 300 |
| Start date | May 17, 2023 |
| Primary completion | Jan 1, 2026 |
| Completion | Jul 1, 2027 |
| First posted | May 11, 2023 |
| Last update posted | Jul 31, 2025 |
| Countries | United States |
At a glance
- 10–99 Study sites
- No Results posted
- 10–99 FDA inspections linked to this trial
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: