An interventional study of C-MIC system in Systolic Left Ventricular Dysfunction, sponsored by Berlin Heals GmbH. Recruiting at 6 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by Berlin Heals GmbH · Not applicable, Interventional, and Treatment
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.
260 studies on the registry are indexed under Ventricular Dysfunction, Left; 57 are open to participants now.
This study's planned enrollment of 31 is below the median of 100 across 151 interventional studies indexed under Ventricular Dysfunction, Left.
Browse Ventricular Dysfunction, Left studies →Berlin Heals GmbH is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device plus Standard of Care
Device: C-MIC system
This study aims to follow up patients already treated with a C-MIC System over a period of 2 years following the initial treatment with the device, to assess the long term results.
Mortality
Rate of all cause, cardiac and device related mortality
Time frame: 2 years
Hospitalizations
Rate of all-cause, cardiac and device related hospitalizations
Time frame: 2 years
Adverse events
Overall incidence and severity of adverse events including malfunction
Time frame: 2 years
Change in cardiac performance
Left ventricular ejection fraction
Time frame: 2 Years
Treatment adjustment
Need for prolonged therapy with the C-MIC System in responder patients
Time frame: 2 Years
Patient related outcome
Kansas City Cardiomyopathy Questionnaire (KCCQ: 0-100). Higher score represent better health status
Time frame: 2 years
Change in New York Heart Association (NYHA) classification
NYHA functional class
Time frame: 2 years
Cange in exercise ability
Cardiopulmonary exercise test
Time frame: 2 years
Change in aerobic capacity and endurance
6 Minute walk test
Time frame: 2 years
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Ventricular Dysfunction, Left →
Berlin Heals GmbH