Trials / Active Not Recruiting
Active Not RecruitingNCT05855135
Assessment of Combined CCM and ICD Device in HFrEF
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
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Impulse Dynamics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
- Ventricular Fibrillation
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2023-05-17
- Primary completion
- 2026-01-01
- Completion
- 2027-07-01
- First posted
- 2023-05-11
- Last updated
- 2025-07-31
Locations
59 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05855135. Inclusion in this directory is not an endorsement.