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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Incidence rate of composite endpoint events
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence rate of composite endpoint events
时间窗: 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)
时间窗: 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
次要结局
未报告次要终点