TRICUS STUDY Euro - Safety and Efficacy of the TricValve® Device

Severe Tricuspid Regurgitation Clinical Trial

Official title: TRICUS STUDY EURO - Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation

Status Completed

Clinical Trial Summary

The TricValve® Transcatheter Bicaval Valves System is indicated for relief of tricuspid insufficiency in patients with symptomatic heart disease who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy.

Clinical Trial Description

TricValve® Transcatheter Bicaval Valves is a system of two self-expanding biological valves for the treatment of patients with hemodynamically relevant tricuspid insufficiency and caval reflux. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. It is especially intended for use for patients at extreme risk or who are inoperable for open surgical therapy. Pre-Clinical and Clinical preliminary studies have shown an acceptable safety and performance profile of the TricValve® Transcatheter Bicaval Valves System. Given that the medical device is a potential long-term treatment for patients with tricuspid insufficiency, clinical data for long-term treatment periods is necessary. Thus, the current study with the aim of CE certification is designed to investigate the safety and performance for at least 30 days and up to 6 months. ;

Related Conditions & MeSH terms

• Severe Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

• NCT number: NCT04141137
• Study type: Interventional
• Source: P+F Products + Features GmbH
• Status: Completed
• Phase: N/A
• Start date: December 9, 2019
• Completion date: December 2, 2021