Core Insights - The TRINITY clinical trial results for LuX-ValvePlus were presented at the 2025 New York Valve Conference, demonstrating its safety and efficacy in patients with severe tricuspid regurgitation and high surgical risk [1][2] Group 1: Clinical Trial Overview - TRINITY is a global, prospective, multi-center, single-arm clinical trial involving 149 patients from 20 centers, primarily located in Europe [1] - The average age of patients was 77.4 years, with a high Tri-Score of 13.6%, indicating significant comorbidities [1] - Over 75% of patients used valve sizes of 55mm, 60mm, 65mm, and 70mm, with a notable percentage showing severe to torrential tricuspid regurgitation [1] Group 2: Efficacy Results - 95.7% of patients showed no moderate or greater regurgitation at 30 days post-procedure, with 95.4% of large annulus patients and 100% of small annulus patients achieving this outcome [3] - 84.1% of patients improved to New York Heart Association functional class I/II, with similar rates for both large and small annulus groups [3] - Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, improved by an average of 14 points, with large annulus patients showing a 15-point increase [3] Group 3: Safety Results - The overall device success rate was 97% for large annulus patients and approximately 94% for small annulus patients [2] - The 30-day composite event rate was 14.8%, with low rates of cardiovascular mortality (1.3%) and myocardial infarction (0.0%) [2][3] - The study indicated a low incidence of serious adverse events, suggesting a favorable safety profile for LuX-ValvePlus in treating severe tricuspid regurgitation [3]
健世科技-B(09877)：LuX-Valve Plus TRINITY研究中大瓣环患者30天临床随访结果于美国2025年纽约瓣膜会发布