Performance and Safety of the Cardiac Microcurrent Therapy System

NCT04662034 | Completed DMC

• 1 other identifier: CMIC-II
• Study Type: interventional
• Target: 70
• Locations: 11 countries
• Sites: 20

Brief 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

Outcome Measures

Primary Outcomes (1)

• Performance

  Change of the left ventricular ejection fraction (LVEF) from baseline

  6 months

Study Arms (2)

Device plus Standard of Care

EXPERIMENTAL

Device plus Standard of Care

Device: CMIC; Drug: Standard of Care (SOC)

Standard of Care

OTHER

Standard of care drug treatment

Drug: Standard of Care (SOC)

Interventions

CMIC DEVICE

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.

Device plus Standard of Care

Standard of Care (SOC) DRUG

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

Also known as: Standard drug therapy

Device plus Standard of Care; Standard of Care

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 dilative cardiomyopathy who have systolic left ventricular dysfunction despite of adequate therapy of heart failure (NYHA III - IV (ambulatory)).
• Patients with symptomatic chronic heart failure for more than 1 year and less than 5 years at screening.
• Patient who understands the nature of the procedure and on-going device therapy. Patient is informed about their participation in a chronic human study 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 will not further improve cardiac function. Accordingly, battery life is limited. Furthermore, the patient is informed about the possibility for 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 study regimen and to return for all follow-up visits.
• Patients are receiving guideline conform heart failure therapy
• Patients who are able to perform a 6-minute walk test.
• Patients must have a body mass index within the range of 20 - 36 kg/m².
• Informed consent in writing from patient.
• Patients with an ICD systems can be included providing patients are not pacemaker dependent and the ICD system uses a single coil electrode the leads can be implanted in such a way that it is ensured, that the metal parts of the coil electrodes do not touch each other.

You may not qualify if:

• 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 enrollment.
• 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 a genetic connective tissue disease (for example Marfan syndrome).
• Patients with constrictive pericarditis.
• 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).
• Patients who have other preexisting epicardial leads.
• Patients who have undergone prior heart surgery.
• 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 an ICD system who are pacemaker dependent
• Patients with an ICD system with a dual coil electrode.

Sponsors & Collaborators

• Berlin Heals GmbH: lead

Study Sites (20)

University Clinic

Banja Luka, 78000, Bosnia and Herzegovina

Location

University Clinic Sarajevo

Sarajevo, 71000, Bosnia and Herzegovina

Location

Diagnostic and Consultative Center Neoclinic Ead

Sofia, 1408, Bulgaria

Location

Clinical Hospital Dubrava

Zagreb, 10000, Croatia

Location

HNA Homolce Hospital

Prague, Czech Republic, 15030, Czechia

Location

German Heart Center Charité

Berlin, 13353, Germany

Location

Vivantes Humbold Clinic

Berlin, 13509, Germany

Location

Heart Center Dresden

Dresden, Germany

Location

Medical University Hannover

Hanover, Germany

Location

University Hospital Regensburg

Regensburg, Germany

Location

St. Luke´s Hospital

Thessaloniki, Greece

Location

University Clinic Skopje

Skopje, 1000, North Macedonia

Location

Polish-American Heart Clinic

Bielsko-Biala, 43316, Poland

Location

University Hospital Wroclaw

Wroclaw, Poland

Location

Clinical Center of Serbia

Belgrade, Serbia

Location

Clinical Hospital Center Bezanijska Kosa

Belgrade, Serbia

Location

Institute of Cardiovascular Diseases Dedinje

Belgrade, Serbia

Location

Institute of Cardiovascular Diseases

Kamenitz, 21204, Serbia

Location

Bellvitge University Hospital

Barcelona, Spain

Location

Universitaetsspital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

• Rame JE, Schmitto JD, Kosevic DN, Kovacevic-Preradovic T, Jovev S, Zdravkovic M, Granov N, Popov T, Rudez I, Vukovic P, Ristic V, Neuzil P, Holtdirk A, Ruhparwar A, Khan MS, Dungen HD, Brandes K, Goettel P, Mueller J, Kallel F, Friede T, Peric M, Fudim M, Anker SD; C-MIC II Trial Investigators. Cardio-microcurrent device treatment for heart failure with reduced ejection fraction: Results from the C-MIC II open-label randomized controlled trial. Eur J Heart Fail. 2025 Oct;27(10):1837-1849. doi: 10.1002/ejhf.3763. Epub 2025 Jul 15.

  PMID: 40660878 RESULT

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Peter Goettel, MD

  Berlin Heals GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Device vs Standard of Care, no masking possible
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 10, 2020
• Study Start: February 5, 2021
• Primary Completion: November 13, 2024
• Study Completion: November 13, 2024
• Last Updated: February 6, 2026

Record last verified: 2025-03

Locations

CZ (1); PL (2); CH (1); BO (2); DE (5); SE (4); ES (1); CR (1); NO (1); GR (1); BU (1)