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

This study evaluates the safety and performance/effectiveness of the C‐MIC System, anactive implantable medical device designed to treat patients with heart failure withreduced ejection fraction (HFrEF). The system delivers a non‐excitatory, constant directelectrical 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 dilatedcardiomyopathy who have symptomatic, ambulatory heart failure despite receivingguideline‐directed medical therapy. Eligible patients must have a left ventricularejection fraction (LVEF) between ≥20% and ≤40%.The device is implanted in the catheterization laboratory using a minimally invasiveprocedure that does not require open‐heart surgery. Following implantation, patientsreceive C‐MIC Therapy for a duration of six months. The therapy is designed to improveleft 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.