Tricuspid Regurgitation (TR)
Conditions
Keywords
Tricuspid Regurgitation (TR), Transcatheter tricuspid valve replacement, TTVR
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).
Interventions
DEVICETransvenous Tricuspid Valve System implantation + OMT
Transvenous tricuspid valve replacement with Lux-Valve Plus System in patients with severe or greater Tricuspid Regurgitation despite optimal medical therapy (OMT)
DRUGOMT
Optimal medical therapy (OMT) as the control group for patients with severe or greater tricuspid regurgitation
Sponsors
Jenscare Scientific
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of composite endpoint events | 6 months post-treatment | Percentage (%) of participants achieving composite clinical success at 6 months. Composite clinical success is defined as meeting all of the following criteria: 1. Alive; 2. No heart failure rehospitalization; 3. Reduction in tricuspid regurgitation severity by ≥1 grade from baseline; 4. Improvement in New York Heart Association (NYHA) functional class by ≥1 class from baseline. |
| Rate of Major Adverse Events (MAE) | 30 Day Post-treatment | The major adverse event (MAE) rate is defined as the occurrence of any of the following: Cardiac death Myocardial infarction Stroke New-onset renal failure requiring renal replacement therapy after the procedure Major bleeding (Grade ≥3b according to TVARC) Tricuspid valve re-intervention Device puncture site and vascular access complications Major cardiac structural complications Device-related pulmonary embolism Arrhythmia or conduction block requiring permanent pacemaker implantation |
Countries
China
Outcome results
None listed