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.
Target patients for the C-MIC System are patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA class III - NYHA class IV) despite adequate therapy of heart failure and a left ventricular ejection fraction ranging from 25% to 35% with a history of heart failure of more than 1 year but less than 5 years. In previous studies, C-MIC was successfully implanted with one of the electrodes (the LV patch electrode) being placed directly on the heart with the necessity to perform a thoracotomy. In this study the the LV patch electrode will be placed in 2 different locations outside of the ribcage so that there is no need to perform a thoracotomy and in a 3rd group, a coronary sinus electrode is placed instead. In group 1, the LV patch electrode will be placed in a left-thoracic position into a subcutaneous pocket. In group 2, the LV patch electrode will be placed into one subcutaneous, infraclavicular pocket together with the microcurrent device itself. In group 3, the LV patch electrode will be replaced with a coronary sinus electrode that is placed transvenously. In all the groups, the effect of the microcurrent therapy will be assessed by comparing LV election fraction changes between baseline and after 6 months of microcurrent treatment (primary endpoint).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
33
An implantable device that emits a weak direct (DC)-microcurrent directly to the heart, using a coil electrode that is transvenously placed in the right ventricle and a patch electrode that is placed in a left thoracic subcutaneous pocket
An implantable device that emits a weak direct (DC)-microcurrent directly to the heart, using a coil electrode that is transvenously placed in the right ventricle and a patch electrode that is placed in the same infraclavicular pocket as the device itself
An implantable device that emits a weak direct (DC)-microcurrent directly to the heart, using a coil electrode that is transvenously placed in the right ventricle and a coronary sinus electrode
University Clinical Center of the Republic of Srbska
Banja Luka, Republic of Srbska, Bosnia and Herzegovina
NOT_YET_RECRUITINGInstitute of Cardiovascular Disease Dedinje
Belgrade, Serbia
RECRUITINGLV ejection fraction change from baseline
Change of LV ejection fraction from baseline to 6 months as measured by echocardiography with Corelab. Difference in means between the two timepoints evaluated separately for each group.
Time frame: 6 months
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