Performance and Safety of the Cardiac Microcurrent Therapy System (NCT04662034) | Clinical Trial Compass
CompletedNot Applicable
Performance and Safety of the Cardiac Microcurrent Therapy System
Bosnia and Herzegovina, Bulgaria, Croatia70 participantsStarted 2021-02-05
Plain-language summary
Patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA III - IV) despite adequate therapy according to treatment guidelines of heart failure and who have a baseline left ventricular ejection fraction of ≥25% and ≤35 will receive a C-MIC System and microcurrent therapy after device implantation with optimal medical management. At the end of the study after 6 months, the C-MIC System will be turned off. The control group will receive optimal medical management without device implantation.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction despite of 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.
* Patients who have a baseline left ventricular ejection fraction of ≥25% and ≤35% assessed by echocardiography within 30 days prior to study inclusion.
* Patient who understands the nature of the procedure and on-going device therapy. Patient is informed about their participation in a chronic human study 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 will not further improve cardiac function. Accordingly, battery life is limited. Furthermore, the patient is informed about the possibility for 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 study regimen and to return for all follow-up visits.
* Patients are receiving guideline conform heart failure therapy
* Patients receiving appropriate, stable guideline conform anti-heart failure therapy during the 3 months prior study inclusion (OMM). Stable is defined as no more than a 50% increase or 50% decrease in dose. If the patient is intolerant to fu…