JENSCARE-B (09877) announced that the 12-month clinical follow-up results for large annulus patients from the global multicenter clinical trial (EU TRINITY) of the LuX-Valve Plus transcatheter tricuspid valve replacement system were presented at EuroPCR 2026 (the 2026 European Conference on Cardiovascular Interventions). The results demonstrated the system's large-size advantage, which is expected to address a broad range of unmet clinical needs.

The presentation of the 12-month clinical follow-up results for large annulus patients in the LuX-Valve Plus EU TRINITY study was delivered by Professor Thomas Modine from the University Hospital of Bordeaux, France.

The EU TRINITY study is a global, prospective, multicenter, single-arm clinical trial primarily designed to evaluate the safety and efficacy of LuX-Valve Plus in patients with severe tricuspid regurgitation who are at high surgical risk. The study enrolled 161 patients from 20 centers worldwide (full analysis set plus learning curve), with 18 centers located in France, Germany, Spain, Denmark, and the United Kingdom.

Patients with severe tricuspid regurgitation often present with right heart and tricuspid annulus dilation, which is a major factor increasing the difficulty of interventional treatment for tricuspid regurgitation. Safe and effective clinical treatment options for large annulus patients are scarce, representing a significant unmet clinical need.

The LuX-Valve Plus system is available in seven sizes ranging from 40mm to 70mm. In the EU TRINITY study, over 75% of patients received valve sizes of 55mm, 60mm, 65mm, and 70mm. This subgroup had an average age of 77 years and an average Tri-Score as high as 13.6%. The distribution of tricuspid regurgitation severity in this group was 9.7% severe, 47.8% massive, and 42.5% torrential.

The 12-month clinical follow-up results demonstrated the excellent efficacy and safety of LuX-Valve Plus in large annulus patients: (1) Regarding improvement in tricuspid regurgitation grade, 97.8% of large annulus patients showed no more than moderate regurgitation. (2) Regarding improvement in New York Heart Association functional class, 91.6% of large annulus patients improved to Class I/II post-procedure. (3) Regarding quality of life improvement, large annulus patients showed an average increase of approximately 17 points on the Kansas City Cardiomyopathy Questionnaire score. Additionally, the average 6-minute walk distance for these patients increased by about 43 meters.

Although baseline data indicated that large annulus patients presented with more severe conditions preoperatively—including higher grades of tricuspid regurgitation, greater surgical risk, poorer right ventricular function, larger right atrial volume, and greater tricuspid annular dilation—along with more complex anatomy, the 12-month clinical follow-up results from the EU TRINITY study showed that LuX-Valve Plus maintained consistent, excellent safety and efficacy in this challenging patient population. The results indicated significant improvement in tricuspid regurgitation grade, sustained enhancement of cardiac function due to right heart reverse remodeling, a marked improvement in quality of life, and a maintained low rate of composite adverse events.