C-MIC II follow-up for people with an implanted heart microcurrent device
The C-MIC-II Follow-Up Study
NA · Berlin Heals GmbH · NCT05189860
This follow-up will see if the implanted C‑MIC microcurrent device continues to work safely and help people with systolic left ventricular dysfunction who already received it.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Berlin Heals GmbH (industry) |
| Locations | 6 sites (Banja Luka, Banja Luka and 5 other locations) |
| Trial ID | NCT05189860 on ClinicalTrials.gov |
What this trial studies
The study follows patients who previously received the implanted C‑MIC System, which delivers a small electrical micro‑current to the heart via transvenous and epicardial leads connected to an implanted power source. Participants will have scheduled follow-up visits during the intended 6‑month therapy period to capture device readouts and clinical status using a Portable User Terminal for programming and data download. The protocol focuses on device performance, safety, and clinical course in the original implant recipients rather than new implantations. Data collection will occur at three regional clinical centers where the original implants were performed.
Who should consider this trial
Good fit: Ideal candidates are people who received the C‑MIC System during the prior C‑MIC‑II implantation and can provide written informed consent and attend follow-up visits.
Not a fit: People who did not receive the C‑MIC implant, those who cannot attend study visits, or vulnerable patients excluded by the protocol are not expected to benefit from participation.
Why it matters
Potential benefit: If successful, continued microcurrent therapy could help reduce symptoms and improve heart function and quality of life for people with systolic left ventricular dysfunction.
How similar studies have performed: Early, small clinical programs of cardiac microcurrent therapy have reported promising signals, but larger definitive trials are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Banja Luka, Banja Luka and 5 other locations
- University Clinical Centre of Republic of Srpska — Banja Luka, Banja Luka, Bosnia and Herzegovina (NOT_YET_RECRUITING)
- University Clinical Center of Sarajevo — Sarajevo, Sarajevo, Bosnia and Herzegovina (NOT_YET_RECRUITING)
- Clinical Hospital Dubrava — Zagreb, City of Zagreb, Croatia (RECRUITING)
- University Clinic Cardiac Surgery — Skopje, North Macedonia (RECRUITING)
- Clinical Center of Serbia — Belgrade, Serbia (RECRUITING)
- Clinical Hospital Center Bezanijska Kosa — Belgrade, Serbia (RECRUITING)
Study contacts
- Study coordinator: Peter Goettel, MD
- Email: goettel@berlinheals.de
- Phone: +49 30 88913640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Systolic Left Ventricular Dysfunction