TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (TRINITY-US)

NAActive, not recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

September 26, 2024

Primary Completion Date

October 2, 2025

Study Completion Date

October 31, 2030

Conditions
Tricuspid Regurgitation (TR)
Interventions
DEVICE

Transcatheter Tricuspid Valve Intervention

Due to unsustainable effect of medical therapy and high risks of surgical treatment, transcatheter tricuspid valve intervention (TTVI) has been a major field of study in the world in the last 10 years. TTVI could potentially reduce TR with lower periprocedural risk and improve the patient's clinical status and prognosis. Per the ESC guidelines for surgical and interventional treatment of tricuspid regurgitation (2021 ESC/EACTS Guidelines for the Management of Valvular Heart Disease), Transcatheter intervention for symptomatic secondary severe TR may be considered in inoperable patients at a Heart Valve Centre with expertise in the treatment of tricuspid valve disease (Class IIb). 20 Transcatheter tricuspid treatment options can be divided into categories based on their mechanism of action: coaptation enhancement (edge-to-edge repair and spacer device), annuloplasty devices, caval valve implantation and valve replacement.

Trial Locations (3)

10467

Montefiore Medical Center, New York

48202

Henry Ford Health System, Detroit

90048

Cedars-Sinai Medical Center, Los Angeles

Sponsors
All Listed Sponsors
collaborator

Cardiovascular Research Foundation, New York

OTHER

lead

Jenscare Innovation Inc.

INDUSTRY

NCT06568003 - TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (TRINITY-US) | Biotech Hunter | Biotech Hunter