Heart failure & cardiomyopathies
Two-Year Outcomes of a Cardiac Microcurrent Device in Chronic Heart Failure: A First-In-Human Pilot Study
Authors' conclusion
Long-term use of the C-MIC device appears safe with sustained improvements in NYHA class, LVEF, 6 min walk distance and quality of life
Study context
- Population
- Patients with chronic HF (New York Heart Association (NYHA) class III, mean left ventricular ejection fraction (LVEF) 31.7 ± 3.7%) from the initial C-MIC pilot study alive at 6 monthsof 10 in initial study
- Participants
- 7 patients
- Outcome
- All-cause, cardiac- and device-related mortality; all-cause, cardiac and device-related hospitalisations; adverse events, device malfunctions and exchanges
- Follow-up
- 2 years
Methodological detailssingle-group
- Single-group
Main finding
As reported in the abstract
Safety (primary endpoint)
Device-related adverse events
0
Non-cardiac, non-device-related death at 18 months
1
Observational data: associations, not effects.
Secondary outcomes
LVEF change from baseline · 2 years post-C-MIC deactivation
| Increase from baseline (%) (95% CI) | P value | ||
|---|---|---|---|
| C-MIC | 12.56 (4.67–20.45) | P = 0.002 | |
| −100102030Difference, % (linear scale) |
| Outcome | Estimate | P value |
|---|---|---|
| LVEF change from baseline · 6 months | improvement from baseline 11.60 % (95% CI 5.64–17.56) | P < 0.001 |
| 6-min walk distance change from baseline · 6 months | improvement from baseline 206.35 m (95% CI 161.32–251.39) | P < 0.0001 |
| 6-min walk distance change from baseline · 2 years | above baseline 191 m (95% CI 131.83–250.99) | P < 0.0001 |
NYHA class and SF-36 quality of life · 2 years
- Improvements seen at 6 months preserved throughout 2-year follow-up
Need for prolonged therapy
- Patients requiring C-MIC reactivation
- 1
Adverse events and deaths · 2 years
- Device-related adverse events
- 0
- Non-cardiac, non-device-related death at 18 months
- 1
Original publication
Two-Year Outcomes of a Cardiac Microcurrent Device in Chronic Heart Failure: A First-In-Human Pilot Study. ESC Heart Fail. Published 9 July 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →