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RECRUITING
NCT06920030
NA

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

Sponsor: Berlin Heals GmbH

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2025-04-09

Completion Date

2027-04

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

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.

Locations (4)

University Clinical Center of the Republic of Srbska

Banja Luka, Republic of Srbska, Bosnia and Herzegovina

Institute of Cardiovascular Disease Dedinje

Belgrade, Serbia

Clinical Hospital Center Bezanijska kosa

Belgrade, Serbia

UKC Kragujevac

Kragujevac, Serbia