NCT03621436

Clinical Evaluation of the TRVD™ System in ADHF

Clinical Evaluation of the Transcatheter Renal Venous Decongestion (TRVD™) System for Renal Venous Decongestion in Patients With Acute Decompensated Heart Failure (ADHF)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Magenta Medical Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Heart Failure
• Congestive Heart Failure
• Heart Failure, Congestive

Interventions

Type	Name	Description
DEVICE	TRVD Therapy	A catheter-mounted expandable flow pump is to be deployed in a transfemoral venous catheterization procedure. Once in place, renal venous pressure is reduced to a pre-selected physiologic target pressure and kept there for up to 24 hours. After termination of TRVD therapy, the device is removed.

Timeline

• Start date: 2015-08-07
• Primary completion: 2019-04-01
• Completion: 2019-05-01
• First posted: 2018-08-08
• Last updated: 2019-08-15

Locations

3 sites across 3 countries: Belgium, Croatia, Serbia