The C-MIC II follow-up study: safety and efficacy results 12 months after deactivation of cardiac microcurrent therapy
Year: 2026
Type: article
Abstract: BACKGROUND: The C-MIC II trial demonstrated benefits of 6 months of cardiac microcurrent (C-MIC) therapy in patients with non-ischemic heart failure with reduced ejection fraction (HFrEF). The prospective C-MIC II Follow-Up Study evaluates safety and efficacy outcomes post-device deactivation. METHODS: Primary safety-related endpoints included all-cause, cardiovascular and device-related mortality and hospitalizations and adverse events (AEs). Secondary efficacy-related endpoints included changes in left ventricular ejection fraction (LVEF), Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS), 6-minute walk distance (6MWD), New York Heart Association (NYHA) class and device reactivation rate. Here, we report 12-month results comparing the 6-month time-point (at the end of active therapy) with the 18-month time-point (12 months post-deactivation). RESULTS: Of 32 eligible patients, 31 (97%) were enrolled. At 12 months post-device deactivation, 3 patients (10%) were hospitalized and 1 died (3%); none were device-related. One device-related AE occurred and resolved completely. Improvements in LVEF (vs pre-implantation: +6%; 95% CI 5-8; p<0.0001) and KCCQ-OSS (vs pre-implantation: +43 points; 95% CI 36-49; p<0.0001) were sustained and unchanged from 6 months (LVEF: -0.1%; 95% CI -2-2; p=0.87; KCCQ-OSS:-2; 95% CI -8-4; p=0.49). The 6MWD remained improved (vs pre-implantation: +150 m; 95% CI 109-191; p<0.0001), with a modest decrease (-31 m; 95% CI -56- -7; p=0.013) from 6 months. Improvements in NYHA class (≥1-class improvement in 77% patients) were sustained. Three (10%) patients required device reactivation. CONCLUSION: Among patients previously treated with C-MIC device, improvements in LVEF, 6MWD, NYHA class and KCCQ-OSS were sustained, with a favorable safety profile 12 months post-deactivation.
DOI: 10.1093/ejhf/xuag274
Institutions: Thomas Jefferson University, Institut za kardiovaskularne bolesti Dedinje, University of Banja Luka, Ss. Cyril and Methodius University in Skopje, University Hospital Medical Center Bezanijska kosa, Clinical Center University of Sarajevo, Institute for Cardiovascular Diseases of Vojvodina, University Hospital Dubrava, University of Belgrade, Universitätsmedizin Göttingen, German Centre for Cardiovascular Research, University of Göttingen, Heart Hospital Baylor Plano, Baylor Scott & White Health, Baylor Scott & White Research Institute, Duke University, Deutsches Herzzentrum der Charité, Berlin-Brandenburger Centrum für Regenerative Therapien, Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Charité - Universitätsmedizin Berlin
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,300
OpenAlex ID: W7204220828
FWCI:
Cites:
Cited by:
Related to: