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

NCT06920030 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • SCIRENT Clinical Research and Science d.o.o.

    collaborator UNKNOWN

  • Berlin Heals GmbH

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-09
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • Bosnia and Herzegovina
  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06920030 on ClinicalTrials.gov