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

Patients with idiopathic dilated cardiomyopathy in heart failure (NYHA class III - IV) with a baseline left ventricular ejection fraction between ≥25% and ≤35%, and patients with non-ischemic cardiomyopathy in heart failure (NYHA class III-IV) with a baseline left ventricular ejection fraction \>40% and \<50% despite guideline-directed medical therapy, will receive C-MIC treatment in addition to optimal medical management. The device can be implanted without the need for open-heart surgery. Patients are assigned to one of two groups according to the indications under investigation. At the end of the study after 6 months, the C-MIC System will be turned off. The primary endpoint of the study is the absolute change in left ventricular ejection fraction after 6 months of treatment.

NCT Number	NCT06920030
Lead Sponsor	Berlin Heals GmbH Collaborators: SCIRENT Clinical Research and Science d.o.o.
Conditions	Idiopathic Cardiomyopathy, Left Ventricular (LV) Systolic Dysfunction, Non-ischemic Cardiomyopathy
Enrollment	22 participants
Start Date	2025-04-09
Primary Completion	2027-04 (estimated)
Study Completion	2027-04 (estimated)
Updated on ClinicalTrials.gov	2026-08-11