The C-MIC-II Follow-Up Study (C-MIC-II-FU)
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- STATUS
- Recruiting
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- End date
- Jun 15, 2025
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- participants needed
- 50
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- sponsor
- Berlin Heals GmbH
Summary
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.
Description
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.
Details
| Condition | Systolic Left Ventricular Dysfunction |
|---|---|
| Treatment | C-MIC system |
| Clinical Study Identifier | NCT05189860 |
| Sponsor | Berlin Heals GmbH |
| Last Modified on | 3 April 2023 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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