Patients with idiopathic dilated cardiomyopathy in heart failure (NYHA class III - IV) with a baseline left ventricular ejection fraction between ≥25% and ≤35%, and patients with non-ischemic cardiomyopathy in heart failure (NYHA class III-IV) with a baseline left ventricular ejection fraction \>40% and \<50% despite guideline-directed medical therapy, will receive C-MIC treatment in addition to optimal medical management.
The device can be implanted without the need for open-heart surgery. Patients are assigned to one of two groups according to the indications under investigation. At the end of the study after 6 months, the C-MIC System will be turned off. The primary endpoint of the study is the absolute change in left ventricular ejection fraction after 6 months of treatment.
Patients with idiopathic dilated cardiomyopathy who have systolic left ventricular dysfunction despite adequate therapy of heart failure (NYHA III - IV).
Patients who have a baseline left ventricular ejection fraction of ≥25% and ≤35% assessed by corelab.
Patients with non-ischemic cardiomyopathy with mildly reduced left ventricular ejection fraction despite adequate therapy of heart failure (NYHA III - IV).
Patients who have a baseline left ventricular ejection fraction of >40% and <50% assessed by corelab.
Patients who have a potentially correctible cause of heart failure, such as 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 30 days before screening.
Patients with systolic blood pressure above 150 mmHg and diastolic blood pressure above 90 mmHg despite optimal antihypertensive medical treatment.
Parallel
Subcutaneous cardiac microcurrent treatment
DeviceAn implantable device that emits a weak direct (DC)-microcurrent directly to the heart.
Subcutaneous cardiac microcurrent treatment
DeviceAn implantable device that emits a weak direct (DC)-microcurrent directly to the heart.
Left ventricular ejection fraction (LVEF) change from baseline
Absolute change of the left ventricular ejection fraction (LVEF) from baseline to 6 months as measured by echocardiography with Corelab. The changes from baseline will be analyzed by using the Mixed Model for Repeated Measures (MMRM), with the baseline value as covariate.
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Berlin Heals GmbH
Lead sponsor
SCIRENT Clinical Research and Science d.o.o.
Collaborator