Clinical Evaluation of the TRVD™ System in ADHF

A prospective, multi-national, open-label clinical study which is conducted to asses the safety, feasibility and performance of the TRVD™ System in hospital-admitted patients with Acute Decompensated Heart Failure (ADHF) and evidence of reduced left ventricular ejection fraction. The study will include patients who present with significant venous congestion, as evidenced by clinical, laboratory and imaging signs of fluid retention. Study participation, for each enrolled subject, will last approximately 3 months post index procedure. Patients will be evaluated from enrollment until hospital discharge, then at 30, 60, and 90 days post procedure.