A Study Evaluating an Implantable Cardiac Microcurrent Device in Patients With Chronic Heart Failure

Brief Summary

This study evaluates the safety and performance/effectiveness of the C-MIC System, an active implantable medical device designed to treat patients with heart failure with reduced ejection fraction (HFrEF). The system delivers a non-excitatory, constant direct electrical microcurrent (DC) to the heart with the aim of improving cardiac function. The C-MIC System is intended for use in patients with ischemic or non-ischemic dilated cardiomyopathy who have symptomatic, ambulatory heart failure despite receiving guideline-directed medical therapy. Eligible patients must have a left ventricular ejection fraction (LVEF) between ≥20% and ≤40%. The device is implanted in the catheterization laboratory using a minimally invasive procedure that does not require open-heart surgery. Following implantation, patients receive C-MIC Therapy for a duration of six months. The therapy is designed to improve left ventricular performance, as well as functional capacity and patient well-being, including 6-minute walk distance, quality of life, and New York Heart Association (NYHA) functional class.