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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05855135
Study type Interventional
Source Impulse Dynamics
Contact Elizabeth Shaji
Phone (856) 434-7957
Email eshaji@impulsedynamics.com
Status Recruiting
Phase N/A
Start date May 17, 2023
Completion date December 2025

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