Pilot Study to Investigate the Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead
Patients with idiopathic dilative cardiomyopathy in heart failure (NYHA III - IVa) despite adequate therapy according to treatment guidelines and who have a baseline left ventricular ejection fraction between ≥25% and ≤35% will receive a C-MIC treatment together with optimal medical management. The device will be implanted in 3 different ways without the need to open the chest. Each patient will be assigned to one implantation technique. 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 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 (ambulatory)).
• Patients with symptomatic chronic heart failure for more than 1 year and less than 5 years at screening based on the date of diagnosis.
• Patients who have a baseline left ventricular ejection fraction of ≥25% and ≤35% assessed by corelab echocardiography within 30 days prior to device implantation.
• 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 followup visits.