LuX-Valve Plus System for Severe or Greater Tricuspid Regurgitation

Brief Summary

This clinical trial aims to evaluate the safety and effectiveness of the Transvenous Artificial Tricuspid Valve System, LuX-Valve Plus System, Jenscare Scientific Co., Ltd. The study population consists of high-risk patients with severe or greater tricuspid regurgitation (TR) who are ineligible for surgical intervention and have demonstrated inadequate response to optimized medical therapy (OMT). This is a prospective, multicenter, randomized controlled trial. A total of 111 subjects who meet all inclusion criteria and none of the exclusion criteria will be enrolled. Participants will be randomized in a 2:1 ratio to one of the following groups: Treatment Group: Transvenous Artificial Tricuspid Valve System implantation + OMT Control Group: OMT alone All subjects will undergo serial follow-up assessments pre-treatment, during the treatment period, and post-procedure at 30 days, 3 months, 6 months, 1 year, and annually through 2-5 years. A summary report will be submitted to the regulatory authority at the 6-month time point. Subjects in the treatment group will have one extra follow-up visit at 7 days ± 3 days post-procedure or prior to discharge (whichever occurs first).