LuX-Valve Plus System for Severe or Greater Tricuspid Regurgitation

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).

Inclusion Criteria: * Age ≥ 65 years * Severe or greater TR (TR ≥ 3+ / 4+ by echocardiography) * High surgical risk or inoperable per heart team (TRI-SCORE ≥6, STS ≥8%, EuroSCORE II ≥3%, etc.) AND symptomatic despite GDMT (≥1 month diuretics, stable regimen for ≥2 weeks) * Suitable for TTVR per heart team * NYHA III-IV * Signed ICF and willing to comply with follow-up Exclusion Criteria: * Anatomy unsuitable for device procedure * LVEF \< 50% * SPAP \> 60 mmHg by TTE (unless RHC confirms ≤60 mmHg) * Aortic/mitral/pulmonary valve disease requiring surgery * Prosthetic valve replacement within 6 months or moderate/severe dysfunction * Ebstein anomaly or RV dysplasia * RVOT obstruction or intracardiac mass * Active endocarditis within 90 days, or antibiotics for infection within 14 days * CV/cardiac/cervical surgery within 30 days * Stroke within 90 days * Unable to tolerate anticoagulation/antiplatelet therapy * eGFR \< 30 mL/min/1.73m² or on RRT * MELD-Albumin ≥ 12 * Severe respiratory dysfunction (unsuitable for general anesthesia) * Active GI bleeding/ulcer within 90 days * Cardiogenic shock or hemodynamic instability within 30 days * Untreated severe CAD or ACS within 30 days * Life expectancy ≤ 1 year * Known allergy to device components or study drugs * Pregnancy or lactation (or planned pregnancy) * Enrolled in another interventional trial (not reached primary endpoint) * Other conditions deemed unsuitable per investigator