Performance and Safety of the Cardiac Microcurrent Therapy System

NACompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

February 5, 2021

Primary Completion Date

November 13, 2024

Study Completion Date

November 13, 2024

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

Trial Locations (20)

1000

University Clinic Skopje, Skopje

1408

Diagnostic and Consultative Center Neoclinic Ead, Sofia

4031

Universitaetsspital Basel, Basel

10000

Clinical Hospital Dubrava, Zagreb

13353

German Heart Center Charité, Berlin

13509

Vivantes Humbold Clinic, Berlin

15030

HNA Homolce Hospital, Prague

21204

Institute of Cardiovascular Diseases, Kamenitz

43316

Polish-American Heart Clinic, Bielsko-Biala

71000

University Clinic Sarajevo, Sarajevo

78000

University Clinic, Banja Luka

Unknown

Heart Center Dresden, Dresden

Medical University Hannover, Hanover

University Hospital Regensburg, Regensburg

St. Luke´s Hospital, Thessaloniki

University Hospital Wroclaw, Wroclaw

Clinical Center of Serbia, Belgrade

Clinical Hospital Center Bezanijska Kosa, Belgrade

Institute of Cardiovascular Diseases Dedinje, Belgrade

Bellvitge University Hospital, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Berlin Heals GmbH

INDUSTRY