Severe Tricuspid Regurgitation Clinical Trial
Official title:
TRICUS STUDY - Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation.
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.
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 is designed to investigate the safety and performance for at least 30 days and up to 6 months. The study has been approved by the Kaunas Regional Biomedical Research Ethics Committee. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03416166 -
International Multisite Transcatheter Tricuspid Valve Therapies Registry
|
N/A | |
| Terminated |
NCT02387697 -
Treatment of Severe Secondary TRIcuspid Regurgitation in Patients With Advance Heart Failure With CAval Vein Implantation of the Edwards Sapien XT VALve (TRICAVAL)
|
Phase 2/Phase 3 | |
| Completed |
NCT04141137 -
TRICUS STUDY Euro - Safety and Efficacy of the TricValve® Device
|
N/A |