Clinical Trial

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

Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
The LuX-Valve Plus System is intended for the treatment of patients with at least severe TR who are symptomatic and determined by a Heart Team not to be suitable for surgical treatment. This study aims to assess the safety and effectiveness of the LuX-Valve Plus System in high-surgical risk patients with at least severe tricuspid regurgitation (TR).
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-08-20; most recent amendment 2026-02-26.
Status change: Recruiting → Active, Not Recruiting 2025-10-16
Status change: Not Yet Recruiting → Recruiting 2024-10-23
Trial Details
NCT Number NCT06568003
Lead Sponsor Jenscare Innovation Inc.
Collaborators: Cardiovascular Research Foundation, New York
Conditions Tricuspid Regurgitation (TR)
Enrollment 15 participants
Start Date 2024-09-26
Primary Completion 2025-10-02 (estimated)
Study Completion 2030-10 (estimated)
Updated on ClinicalTrials.gov 2026-03-02