C-MIC II follow-up for people with an implanted heart microcurrent device
Official title: The C-MIC-II Follow-Up Study
Run by Berlin Heals GmbH · NCT05189860 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 31 (estimated) |
| Sponsor | Berlin Heals GmbH Industry-sponsored |
| Locations | 6 sites (Banja Luka, Banja Luka and 5 other locations) |
| Status | Recruiting |
| Started | March 3, 2022 |
| Main results expected | November 15, 2026 |
| Study ends | November 15, 2026 |
| Registry record updated | June 8, 2025 |
| Trial ID | NCT05189860 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Early, small clinical programs of cardiac microcurrent therapy have reported promising signals, but larger definitive trials are still limited.
Who can join: the full rules
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 it's running
-
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 -
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
Study contacts
- Study coordinator: Peter Goettel, MD
- Email: goettel@berlinheals.de
- Phone: +49 30 88913640
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using a new cardiac device to treat heart failure with less invasive techniques
This study is testing a new heart device that can be implanted with less invasive methods to see if it helps people with heart failure feel better and improve heart function.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.