Overview

Performance and Safety of the Cardiac Microcurrent Therapy System

Status:
Recruiting
Trial end date:
2023-08-31
Target enrollment:
Participant gender:
Summary
Patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA III - IV) despite adequate therapy according treatment guidelines of heart failure and who have a baseline left ventricular ejection fraction of ≥25% and ≤35 will receive a C-MIC System and microcurrent therapy after device implantation with optimal medical management. At the end of the study after 6 months, the C-MIC System will be turned off. The control group will receive optimal medical management without device implantation.
Phase:
N/A
Details
Lead Sponsor:
Berlin Heals GmbH