Vsling™ I: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
Trial Parameters
Brief Summary
Prospective, multi-center, open-label clinical study of the feasibility and initial safety and performance of the Vsling™ in patients with heart failure (HF) with evidence of reduced left ventricular ejection fraction, associated with ventricular dilation.
Eligibility Criteria
Inclusion Criteria: 1. Age≥18 years 2. Left ventricular end diastolic diameter is greater than or equal to 55mm 3. Ejection fraction ≥20% and ≤40% 4. FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of echocardiography (via a transthoracic or transesophageal echo) 5. End-systolic Interpapillary muscle distance ≥ 20mm 6. NYHA class II-IVa 7. Cardiomyopathy of ischemic or non-ischemic origins 8. Understands the nature of the study and procedure and able to provide written informed consent Exclusion Criteria: 1. Any evidence of structural (chordal or leaflet) mitral lesions 2. Ventricular tachycardia or ventricular fibrillation within 6 months prior to inclusion in this study 3. Prior mitral valve repair or replacement 4. ICD/CRT/cardiac pacemaker leads implanted within 3 months prior to inclusion in this study 5. Clinical signs of cardiogenic shock within 30 days prior to inclusion in this study 6. Anatomy that, in the opinion of the interventionalist, pre