Pilot Study to Investigate the Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead
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 with symptomatic chronic heart failure for more than 1 year and less than 5 years at screening based on the date of diagnosis.
• Female and male patients aged ≥18 years - 75 years.
• Patient who understands the nature of the procedure and on-going device therapy. Patient is informed about their participation in a chronic clinical trial and about the intended treatment period of 6 months which is derived by the fact that according to current knowledge microcurrent treatment exceeding 6 months will not have additional favorable effects which means it will not further improve cardiac function. Furthermore, the patient is informed about the possibility of device explantation, informed regarding possible risks and is able to give written informed consent prior to any procedures and is considered willing and able to adhere to the study regimen and to return for all follow-up visits.
• Patients receiving appropriate, stable guideline directed medical therapy for heart failure at least for the 3 months prior to screening. Stable is defined as no more than a 50% increase or 50% decrease in dose. If the patient is intolerant of guideline recommended doses of heart failure medication, documented evidence must be available.
• Guideline directed medical therapy includes for:
• • Patients with HFrEF:
• \- Angiotensin-converting enzyme inhibitor (ACE-I) or
• \- Angiotensin receptor-neprilysin inhibitor (ARNI)
• \- Beta-blocker
• \- Mineralocorticoid receptor antagonist (MRA)
• \- Dapagliflozin/Empagliflozin inhibitor (SGLT2i)
⁃ Patients with HFmrEF - Diuretics (if symptomatic)
‣ Dapagliflozin/Empagliflozin inhibitor (SGLT2i)
• Patients who can perform a non-assisted 6-minute walk test.
• Patients must have a body mass index within the range of 20 - 36 kg/m².
• Informed consent in writing obtained from patient.