LuX-Valve Plus System for Severe or Greater Tricuspid Regurgitation

A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of a Transvenous Artificial Tricuspid Valve System in Patients With 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