The C-MIC-II Follow-Up 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. Target patients for this study are patients who have received the device in a prior study.
| Condition(s) | Systolic Left Ventricular Dysfunction |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * Patients who have received a C-MIC System during the C-MIC-II Study. * Informed consent in writing from the patient. Exclusion Criteria: * Patients who are unwilling or unable to participate in the study visits. * Vulnerable Patients. |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Berlin Heals GmbH |
| Locations | Banja Luka, Banja Luka, Bosnia and Herzegovina; Sarajevo, Sarajevo, Bosnia and Herzegovina; Zagreb, City of Zagreb, Croatia; Skopje, North Macedonia; Belgrade, Serbia; Belgrade, Serbia |
| Start date | 2022-03-03 |
| NCT ID | NCT05189860 |
| Official listing | https://clinicaltrials.gov/study/NCT05189860 |