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