RecruitingNot ApplicableNCT06920030

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


Sponsor

Berlin Heals GmbH

Enrollment

22 participants

Start Date

Apr 9, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cardiac device system (C-MIC) that uses tiny electrical currents to help the heart pump better. It involves a less invasive way to place a lead on the left ventricle of the heart. The trial is for people with heart failure who are still struggling despite being on optimal medications. **You may be eligible if...** - You have dilated cardiomyopathy (an enlarged, weakened heart) OR non-ischemic cardiomyopathy with mildly reduced heart pumping ability - Your heart's pumping function (ejection fraction) is between 25–35% or 40–50% depending on which group you fall in - You have had symptomatic heart failure for 1 to 5 years - You are in NYHA class III or IV (moderate to severe symptoms) **You may NOT be eligible if...** - Your heart failure is caused by blocked arteries (ischemic cardiomyopathy) - You have had a heart attack - You already have a cardiac device (pacemaker, defibrillator, or CRT) - Your heart failure symptoms are very new or very long-standing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESubcutaneous cardiac microcurrent treatment

An implantable device that emits a weak direct (DC)-microcurrent directly to the heart.

DEVICESubcutaneous 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

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NCT06920030


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