NCT06920030

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Berlin Heals GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Target patients for the C-MIC System include: (1) patients with idiopathic dilated cardiomyopathy who have systolic left ventricular dysfunction (NYHA class III-IV) despite adequate heart failure therapy and a left ventricular ejection fraction between 25% and 35%, and (2) patients with non-ischemic cardiomyopathy who have systolic left ventricular dysfunction (NYHA class III-IV) despite adequate heart failure therapy and a left ventricular ejection fraction \>40% and \<50%. All patients must have a documented history of heart failure for more than 1 year but less than 5 years. In previous studies, C-MIC was successfully implanted with one of the electrodes (the LV patch electrode) being placed directly on the heart. This study uses a less invasive technique to place the LV patch electrode, eliminating the need for a thoracotomy. In all the groups, the effect of the microcurrent therapy will be assessed by comparing LV ejection fraction changes between baseline and after 6 months of microcurrent treatment (primary endpoint).

Conditions

• Idiopathic Cardiomyopathy
• Left Ventricular (LV) Systolic Dysfunction
• Non-ischemic Cardiomyopathy

Interventions

Type	Name	Description
DEVICE	Subcutaneous cardiac microcurrent treatment	An implantable device that emits a weak direct (DC)-microcurrent directly to the heart.
DEVICE	Subcutaneous cardiac microcurrent treatment	An implantable device that emits a weak direct (DC)-microcurrent directly to the heart.

Timeline

• Start date: 2025-04-09
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2025-04-09
• Last updated: 2026-03-18

Locations

4 sites across 2 countries: Bosnia and Herzegovina, Serbia