Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead

Conditions: Idiopathic Cardiomyopathy, Left Ventricular (LV) Systolic Dysfunction, Non-ischemic Cardiomyopathy

Sex: All

Ages: 18 Years – 75 Years

Healthy volunteers: No

Phase: NA

Enrollment: 22

Sponsor: Berlin Heals GmbH

Location: University Clinical Center of the Republic of Srbska Banja Luka Republic of Srbska

Summary

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 \

Eligibility Criteria

Inclusion Criteria Idiopathic Dilated Cardiomyopathy with HFrEF: 1. Patients with idiopathic dilated cardiomyopathy who have systolic left ventricular dysfunction despite adequate therapy of heart failure (NYHA III - IV). 2. Patients who have a baseline left ventricular ejection fraction of ≥25% and ≤35% assessed by corelab. Inclusion Criteria Non-Ischaemic Cardiomyopathy with HFmrEF: 1. Patients with non-ischemic cardiomyopathy with mildly reduced left ventricular ejection fraction despite adequate therapy of heart failure (NYHA III - IV). 2. Patients who have a baseline left ventricular ejection fraction of \>40% and \

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Source: ClinicalTrials.gov (NCT06920030). StuddyBuddy aggregates publicly available trial information.