This study evaluates the safety and performance/effectiveness of the C-MIC System, an active implantable medical device designed to treat patients with heart failure with reduced ejection fraction (HFrEF). The system delivers a non-excitatory, constant direct electrical microcurrent (DC) to the heart with the aim of improving cardiac function.
The C-MIC System is intended for use in patients with ischemic or non-ischemic dilated cardiomyopathy who have symptomatic, ambulatory heart failure despite receiving guideline-directed medical therapy. Eligible patients must have a left ventricular ejection fraction (LVEF) between ≥20% and ≤40%.
The device is implanted in the catheterization laboratory using a minimally invasive procedure that does not require open-heart surgery. Following implantation, patients receive C-MIC Therapy for a duration of six months. The therapy is designed to improve left ventricular performance, as well as functional capacity and patient well-being, including 6-minute walk distance, quality of life, and New York Heart Association (NYHA) functional class.
Only for Stratum 1: Patients with HFrEF with non-ischemic disease etiology1
Only for Stratum 2: Patients with HFrEF with ischemic disease etiology. All Participants
Informed consent in writing obtained from patient.
Ambulatory patients with symptomatic chronic heart failure in NYHA functional class II-IV at the time of screening lasting for more than 1 year based on the date of diagnosis. Participants in NYHA II at screening must have one documented episode of NYHA III during the prior 6 months with either hospitalization or increase of heart failure medication dosage.
Patients who have a potentially correctible cause of heart failure, such as severe valvular heart disease or congenital heart disease.
Patients with an indication for a CRT system according to current guidelines.
Patients who have been hospitalized for heart failure which required the use of inotropic support within 90 days before screening.
Patients with systolic blood pressure (SBP) above 150 mmHg and diastolic blood pressure (DBP) above 90 mmHg despite optimal antihypertensive medical treatment.
Parallel
Subcutaneous cardiac microcurrent treatment
DeviceThe C-MIC System is implanted subcutaneously using a minimally invasive, non-open-heart procedure performed in a catheterization laboratory. Following randomization, C-MIC Therapy is either inactive or active from Day 1 through Day 180 and active or inactive, respectively, from Day 180 through Day 360.
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score at Month 6
The Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) assesses heart failure symptoms and physical limitations. Scores range from 0 to 100, with higher scores indicating better health status. Change from baseline is calculated as the Month 6 score minus the baseline score; a positive change indicates improvement.
Change From Baseline in 6-Minute Walk Distance at Month 6
The 6-Minute Walk Test measures functional exercise capacity as the distance, in meters, that a participant can walk in 6 minutes. Change from baseline is calculated as the Month 6 distance minus the baseline distance; a positive change indicates improvement.
Ordinal Shift From Baseline in New York Heart Association Functional Class at Month 6
New York Heart Association (NYHA) Functional Class is a clinician-assessed, 4-category ordinal classification of heart failure severity: Class I indicates no limitation of physical activity, Class II indicates slight limitation, Class III indicates marked limitation, and Class IV indicates symptoms at rest. A shift to a lower class indicates improvement, and a shift to a higher class indicates worsening.
Patient Global Assessment of Change Score at Month 6
The Patient Global Assessment of Change is a participant-reported assessment of overall change in health status relative to baseline. It is measured on a 7-point ordinal scale ranging from 1 ("markedly worse") to 7 ("markedly improved"), with 4 indicating "no change." Higher scores indicate a more favorable assessment.
Change in Left Ventricular Ejection Fraction From Month 6 to Month 12
Left ventricular ejection fraction (LVEF) is measured by echocardiography and reported as a percentage. Change is calculated as the Month 12 LVEF minus the Month 6 LVEF. A positive value indicates an increase in LVEF, whereas a negative value indicates a decline. This outcome will assess maintenance of the LVEF improvement observed at the end of the initial 6-month treatment period.
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