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

NCT06920030 | Recruiting

• 1 other identifier: C-MIC-III
• Study Type: interventional
• Target: 22
• Locations: 2 countries
• Sites: 4

Brief 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

Keywords

dilated cardiomyopathy; heart failure; non-ischemic cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction (LVEF) change from baseline

  Absolute change of the left ventricular ejection fraction (LVEF) from baseline to 6 months as measured by echocardiography with Corelab. The changes from baseline will be analyzed by using the Mixed Model for Repeated Measures (MMRM), with the baseline value as covariate.

  6 months

Study Arms (2)

Group 1: Sub-Q implantation

EXPERIMENTAL

The LV patch lead will be implanted in a less invasive way in patients with idiopathic dilated cardiomyopathy.

Device: Subcutaneous cardiac microcurrent treatment

Group 2: Sub-Q implantation

EXPERIMENTAL

The LV patch lead will be implanted in a less invasive way in patients with idiopathic dilated cardiomyopathy and in patients with non-ischemic cardiomyopathy.

Device: Subcutaneous cardiac microcurrent treatment

Interventions

Subcutaneous cardiac microcurrent treatment DEVICE

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

Group 1: Sub-Q implantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with idiopathic dilated cardiomyopathy who have systolic left ventricular dysfunction despite adequate therapy of heart failure (NYHA III - IV).
• Patients who have a baseline left ventricular ejection fraction of ≥25% and ≤35% assessed by corelab.
• Patients with non-ischemic cardiomyopathy with mildly reduced left ventricular ejection fraction despite adequate therapy of heart failure (NYHA III - IV).
• Patients who have a baseline left ventricular ejection fraction of \>40% and \<50% assessed by corelab.
• Patients with symptomatic chronic heart failure for more than 1 year and less than 5 years at screening based on the date of diagnosis.
• Female and male patients aged ≥18 years - 75 years.
• Patient who understands the nature of the procedure and on-going device therapy. Patient is informed about their participation in a chronic clinical trial and about the intended treatment period of 6 months which is derived by the fact that according to current knowledge microcurrent treatment exceeding 6 months will not have additional favorable effects which means it will not further improve cardiac function. Furthermore, the patient is informed about the possibility of device explantation, informed regarding possible risks and is able to give written informed consent prior to any procedures and is considered willing and able to adhere to the study regimen and to return for all follow-up visits.
• Patients receiving appropriate, stable guideline directed medical therapy for heart failure at least for the 3 months prior to screening. Stable is defined as no more than a 50% increase or 50% decrease in dose. If the patient is intolerant of guideline recommended doses of heart failure medication, documented evidence must be available.
• Guideline directed medical therapy includes for:
• Patients with HFrEF:
• \- Angiotensin-converting enzyme inhibitor (ACE-I) or
• \- Angiotensin receptor-neprilysin inhibitor (ARNI)
• \- Beta-blocker
• \- Mineralocorticoid receptor antagonist (MRA)
• \- Dapagliflozin/Empagliflozin inhibitor (SGLT2i)

You may not qualify if:

• Patients who are not likely to experience improvement of their chronic heart failure by the microcurrent therapy, because the causes of the disease cannot be influenced even if the patients fulfill the indication for use of the device or if the therapy with the C-MIC System is not possible or might be associated with unknown risks:
• Patients who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
• Patients with an indication for a CRT system according to current guidelines.
• Patients who have been hospitalized for heart failure which required the use of inotropic support within 30 days before screening.
• Patients with systolic blood pressure above 150 mmHg and diastolic blood pressure above 90 mmHg despite optimal antihypertensive medical treatment.
• Patients with hemoglobin blood level \< 12 g/dl in male and \< 10 g/dl in female patients.
• Patients with primary pulmonary hypertension
• Patients who have genetic connective tissue disease (for example Marfan syndrome).
• Patients with a prosthetic tricuspid valve.
• Patients in whom access for implantation of the leads cannot be obtained (i.e. known venous occlusion, post radiation therapy).
• Patient with other features (i.e. thorax deformity) that in the eyes of the investigator make the straightforward placement of the device seem unlikely.
• Patients with a pacemaker, an ICD system, a CRT system or with a CCM system.
• Current pregnancy or
• Breastfeeding/lactating women
• Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator) 2 months before and until 1 month after C-MIC therapy.

Sponsors & Collaborators

• Berlin Heals GmbH: lead
• SCIRENT Clinical Research and Science d.o.o.: collaborator

Study Sites (4)

University Clinical Center of the Republic of Srbska

Banja Luka, Republic of Srbska, 78000, Bosnia and Herzegovina

RECRUITING

Institute of Cardiovascular Disease Dedinje

Belgrade, 11040, Serbia

RECRUITING

Clinical Hospital Center Bezanijska kosa

Belgrade, 11080, Serbia

RECRUITING

UKC Kragujevac

Kragujevac, 34000, Serbia

RECRUITING

MeSH Terms

Conditions

Cardiomyopathies; Cardiomyopathy, Dilated; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Susanne Becker

CONTACT

+49 308891364053; becker@berlinheals.de

John Brumfield

CONTACT

+49 308891364053; brumfield@berlinheals.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The CMIC-device effect was investigated in previous clinical studies. However, placement of the Left Ventricular Patch Lead up to now requires invasive surgery. This study shall investigate a procedure with less invasive placement of the LV patch lead.

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 9, 2025
• Study Start: April 9, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3); BO (1)