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A Study Evaluating an Implantable Cardiac Microcurrent Device in Patients With Chronic Heart Failure

NCT07795359 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-31

No results posted yet for this study

Summary

This study evaluates the safety and performance/effectiveness of the C-MIC System, an active implantable medical device designed to treat patients with heart failure with reduced ejection fraction (HFrEF). The system delivers a non-excitatory, constant direct electrical microcurrent (DC) to the heart with the aim of improving cardiac function.

The C-MIC System is intended for use in patients with ischemic or non-ischemic dilated cardiomyopathy who have symptomatic, ambulatory heart failure despite receiving guideline-directed medical therapy. Eligible patients must have a left ventricular ejection fraction (LVEF) between ≥20% and ≤40%.

The device is implanted in the catheterization laboratory using a minimally invasive procedure that does not require open-heart surgery. Following implantation, patients receive C-MIC Therapy for a duration of six months. The therapy is designed to improve left ventricular performance, as well as functional capacity and patient well-being, including 6-minute walk distance, quality of life, and New York Heart Association (NYHA) functional class.

Conditions

  • Chronic Heart Failure
  • Left Ventricular (LV) Systolic Dysfunction
  • Ischemic and Non-ischemic Cardiomyopathy

Interventions

DEVICE

Subcutaneous cardiac microcurrent treatment

The C-MIC System is implanted subcutaneously using a minimally invasive, non-open-heart procedure performed in a catheterization laboratory. Following randomization, C-MIC Therapy is either inactive or active from Day 1 through Day 180 and active or inactive, respectively, from Day 180 through Day 360.

Sponsors & Collaborators

  • Berlin Heals GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-09-30
Completion
2028-10-31

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Entities

Diseases

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 NCT07795359 on ClinicalTrials.gov