Assessment of Combined CCM and ICD Device in HFrEF (NCT05855135) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Assessment of Combined CCM and ICD Device in HFrEF
United States300 participantsStarted 2023-05-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient is aged 18 years or older;
✓. Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ;
✓. Patient has HFrEF (LVEF ≤40%);
✓. Patient is on GDMT for heart failure;
✓. Patient has a Class I or Class II indication for an ICD
✓. Patient has a reasonable expectation of meaningful survival of \> 1 year;
✓. Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred;
✓. Patient is willing to give informed consent, available for scheduled study follow-up visits, and able to complete all testing described in the study protocol at the investigational site location.
Exclusion criteria
✕. Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR;
What they're measuring
1
Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective)