Pilot Study of the Cardiac Microcurrent C-MIC System Using a Less Invasive Left Ventricular Lead Implantation for Adults with Idiopathic and Non-Ischemic Cardiomyopathy in Advanced Heart Failure

What this Trial Is About

Researchers are evaluating the use of the Cardiac Microcurrent C-MIC System in patients with idiopathic dilated cardiomyopathy and non-ischemic cardiomyopathy who have heart failure classified as NYHA class III or IV. The study focuses on patients with specific ranges of left ventricular ejection fraction LVEF despite receiving guideline-directed medical therapy. The purpose is to investigate the effect of a less invasive implantation technique of the LV patch lead and to assess changes in heart function after 6 months of treatment. Participants will receive subcutaneous cardiac microcurrent treatment delivered by an implantable device emitting a weak direct current to the heart. The device is implanted using a less invasive method that avoids open-heart surgery. Patients are assigned to one of two groups based on their cardiomyopathy type and treatment indication. The C-MIC System will be active for 6 months during the study and then turned off. During the trial, participants will be monitored with evaluations of heart function, including measurement of left ventricular ejection fraction at baseline and after 6 months. Other assessments include physical ability tests like a 6-minute walk, adherence to medication, and safety monitoring. The study duration includes the 6-month treatment period and follow-up visits to assess outcomes. Researchers aim to determine the change in heart function as the primary outcome measure.

Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead