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The C-MIC System is a medical device used to treat heart failure per the intended purpose which is to treat heart failure by applying an electrical micro-current to the heart. Target patients for this study are patients who have received the device in a prior study.
The C-MIC System is a medical device used to treat heart failure per the intended purpose which is to treat heart failure by applying an electrical micro-current to the heart. The therapy with the C-MIC System is intended to take 6 months. The C-MIC System consists of four parts, of which three are implanted: a transvenous and an epicardial lead and a power source to which the leads are connected. Both leads have the function to transmit micro-current to the heart. A Portable User Terminal (PUT) is needed for programming and readout of the data recorded by the Implantable Microcurrent Device (IMD). Target patients of the C-MIC System at the time of implantation and inclusion in the C-MICII Study were patients with idiopathic dilative cardiomyopathy (NYHA class III - NYHA class who have systolic left ventricular dysfunction despite adequate therapy of heart failure. Target patients for this study are patients who have received the device in a prior study.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
University Clinical Centre of Republic of Srpska
Banja Luka, Banja Luka, Bosnia and Herzegovina
University Clinical Center of Sarajevo
Sarajevo, Sarajevo, Bosnia and Herzegovina
Clinical Hospital Dubrava
Zagreb, City of Zagreb, Croatia
University Clinic Cardiac Surgery
Skopje, North Macedonia
Clinical Center of Serbia
Belgrade, Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, Serbia
Start Date
March 3, 2022
Primary Completion Date
November 15, 2026
Completion Date
November 15, 2026
Last Updated
June 8, 2025
31
ESTIMATED participants
C-MIC system
DEVICE
Lead Sponsor
Berlin Heals GmbH
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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