Congestive Heart Failure Clinical Trial
Official title:
Clinical Evaluation of the Transcatheter Renal Venous Decongestion (TRVD™) System for Renal Venous Decongestion in Patients With Acute Decompensated Heart Failure (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.
n/a
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