Systolic Left Ventricular Dysfunction Clinical Trial
Official title:
Prospective, Randomized, Open, Comparison Study to Demonstrate the Performance and the Safety of Cardiac Microcurrent Therapy (C-MIC) System
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.
Target patients for the C-MIC System are patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA class III - NYHA class IV) despite adequate therapy of heart failure and a left ventricular ejection fraction ranging from 25% to 35% with a history of heart failure of more than 1 year but less than 5 years. Study objective is to determine the safety and effectiveness of C-MIC therapy in patients with moderate to severe heart failure under optimal medical therapy. Data from a pilot study (C-MIC-I) indicate that an increase of ≥ 8% of the left ventricular ejection fraction can be achieved within a treatment period of 6 month. Hence, study hypothesis is that an increase in LVEF of ≥ 8% can be achieved. Subjects will be randomized in a 1:1 ratio to receive the C-MIC System in addition to optimal medical management or to receive optimal medical management alone without device. Due to the risks associated with the implantation, a sham (placebo) procedure is not justified. The primary endpoint will be the change of left ventricular ejection fraction (LVEF) from baseline after 6 months assessed via cardiac ultrasound in %. LVEF measurements will be verified by a core lab at baseline, week 4 (only C-MIC group), month 4 and month 6. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05189860 -
The C-MIC-II Follow-Up Study
|
N/A |