Jenscare’s Lux-Valve Plus TTVR System Evaluated in TRINITY Study

June 9, 2025—Jenscare Scientific Co., Ltd. recently announced that 30-day follow-up results from the TRINITY trial of the company’s Lux-Valve Plus transcatheter tricuspid valve replacement (TTVR) system were presented by Professor Thomas Modine, MD, at EuroPCR 2025.

According to the company, TRINITY is a global prospective, multicenter, single-arm clinical trial evaluating the safety and efficacy of Lux-Valve Plus in patients with severe tricuspid regurgitation (TR) and high surgical risk.

Jenscare stated that the study enrolled 161 patients from 20 global centers (18 centers in France, Germany, Spain, Denmark, and the United Kingdom). The TRINITY data included a full analysis set (FAS) and a roll-in group.

Patients had an average age of approximately 77 years and average Society of Thoracic Surgeons score of 9.92% (14.45% in the roll-in group). The device success rate was approximately 97% with an average procedure time of approximately 41.60 minutes, reported the company.

As summarized in the company’s press release, the composite events rate at 30 days was 14.8% in the FAS (14.9% with the roll-in group included).

Jenscare stated that in the FAS, cardiovascular mortality was 1.3%. The incidence of stroke postprocedure was 0.7%; nonselective tricuspid valve surgery/intervention postprocedure was 0.7%; major cardiac structural complications was 2.0%; severe bleeding was 4.0%; and new pacemaker implantation caused by atrioventricular block was 8.7%.

For the roll-in group, there was one event of nonselective tricuspid valve surgery/intervention postprocedure and new pacemaker implantation.

The company further noted that efficacy indicators showed that TR grade, New York Heart Association (NYHA) classification, and quality of life improved significantly at 30 days.

For the FAS and the roll-in groups, respectively, there was no above-moderate TR in 95.7% and 91.7% of patients; postoperative NYHA class I/II was 84.1% and 58.3%; and the Kansas City Cardiomyopathy Questionnaire score increased by approximately 14 and 18 points on average.

In both groups, there were no significant events reported of myocardial infarction, new onset renal failure, major access site and vascular complications, or device-related pulmonary embolism, stated Jenscare.