A Multi-center, National, Open-label, Prospective Study to Evaluate the Performance of the V-Lap™ System
Trial Parameters
Brief Summary
The objective of this study is to evaluate the safety and performance of the V-LAP System in subjects with New York Heart Association (NYHA) functional class II and III HF, irrespective of left ventricular ejection fraction.
Eligibility Criteria
1. Ischemic or non-ischemic cardiomyopathy and documented heart failure for at least 6 months (diagnosis of HF ≥ 6 months), regardless of ejection fraction. 2. NYHA Class II heart failure (HF) subjects, documented at Baseline Visit regardless of ejection fraction, meeting both inclusion criteria in subsections (2a) and (2b) or NYHA Class III heart failure (HF) subjects, documented at Baseline Visit regardless of ejection fraction, meeting at least one inclusion criteria in subsections (2a) and (2b). 1. Have a minimum of one (1) HF hospitalization or equivalent (HF Emergency Department Visit or HF Urgent Clinic Visit) within the last 12 months associated with signs/symptoms of congestion requiring treatment with intravenous (IV) diuretic. If Cardiac Resynchronization Therapy (CRT) device previously implanted, the HF hospitalization or equivalent must be ≥ 30 days after CRT implantation. 2. Have a corrected\* elevated outpatient Brain Natriuretic Peptide (BNP) level of at least 300 pg/ml