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Performance and Safety of the Cardiac Microcurrent Therapy System

NCT04662034 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-02-06

No results posted yet for this study

Summary

Patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA III - IV) despite adequate therapy according to 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.

Conditions

  • Systolic Left Ventricular Dysfunction

Interventions

DEVICE

CMIC

The C-MIC System consists of three implantable parts: a transvenous and an epicardial lead which are both connected to an implanted power source, and an external programing device. The patch lead is placed over the free wall of the left ventricle and fixated with sutures. When lead placement is achieved, the leads are then tunneled subcutaneously to the infraclavicular region and connected to the power source.

DRUG

Standard of Care (SOC)

Patients receive optimal SOC based defined in pertinent guideline and at the discretion of the investigator

Sponsors & Collaborators

  • Berlin Heals GmbH

    lead INDUSTRY

Principal Investigators

  • Peter Goettel, MD · Berlin Heals GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-02-05
Primary Completion
2024-11-13
Completion
2024-11-13

Countries

  • Bosnia and Herzegovina
  • Bulgaria
  • Croatia
  • Czechia
  • Germany
  • Greece
  • North Macedonia
  • Poland
  • Serbia
  • Spain
  • Switzerland

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 NCT04662034 on ClinicalTrials.gov