Patients with idiopathic dilative cardiomyopathy who have systolic left ventricular
dysfunction (NYHA III - IV) despite adequate therapy according 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.
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.
Study objective is to determine the safety and effectiveness of C-MIC therapy in patients
with moderate to severe heart failure under optimal medical therapy. Data from a pilot study
(C-MIC-I) indicate that an increase of 8% of the left ventricular ejection fraction can be
achieved within a treatment period of 6 month. Hence, study hypothesis is that an increase in
LVEF of 8% can be achieved.
Subjects will be randomized in a 1:1 ratio to receive the C-MIC System in addition to optimal
medical management or to receive optimal medical management alone without device. Due to the
risks associated with the implantation, a sham (placebo) procedure is not justified.
The primary endpoint will be the change of left ventricular ejection fraction (LVEF) from
baseline after 6 months assessed via cardiac ultrasound in %. LVEF measurements will be
verified by a core lab at baseline, week 4 (only C-MIC group), month 4 and month 6.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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