Pivotal TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With Lux Valve Plus System in Patients With Severe or Greater Tricuspid Regurgitation - Clinical SafetY and Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 680
- 试验地点
- 7
- 主要终点
- Rate of Major Adverse Events (MAE)
研究概览
简要总结
The goal of this clinical trial is to learn if LuX-Valve Plus system works to treat symptomatic subjects with at least severe tricuspid regurgitation (TR). It will also learn about the safety of LuX-Valve Plus system.
Researchers will compare LuX-Valve Plus system to a conventional device called EVOQUE to see if LuX-Valve Plus system works to treat subjects with at least severe tricuspid regurgitation.
Participants will:
Undergo one procedure using the LuX-Valve Plus system or EVOQUE after passing screening and enrolling in the trial; Complete follow-up visits and examinations as required by the trial protocol; Report any adverse events
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
- Single (Outcomes Assessor)
盲法说明
Clinical Events Committee
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the randomized study:
- •Subject is at least 21 years of age at time of consent.
- •Subject (or legal guardian) understands trial requirements and treatment procedures and is able to provide written informed consent.
- •Severe or greater TR as assessed on transthoracic echocardiography by core lab.
- •New York Heart Association (NYHA) Class II-IV.
- •On optimal medical therapy (OMT) for TR at the time of baseline assessment per site Heart Team. OMT includes stable oral diuretic medications unless patient has a documented history of intolerance.
- •The site Heart Team concurs that the patient is a good candidate for transcatheter tricuspid valve replacement and suitable for LuX-Valve Plus system by core lab.
- •The commercial sponsor for EVOQUE deems that the patient is a good candidate for EVOQUE valve (control arm).
- •For single arm cohort ("Not Suitable for Conventional TTVI")
- •Meets all criteria 1-6 above
- •The EVOQUE commercial sponsor deems the anatomy unsuitable for EVOQUE tricuspid valve replacement, or the annular perimeter is smaller or greaterthan EVOQUE commercial Instructions for Use (IFU), as determined by the clinical site
- •Two independent Structural Cardiologists determine the patient "Not Suitable" for Transcatheter edge to edge repair
排除标准
- •Left ventricular ejection fraction (LVEF) <35%.
- •Pulmonary arterial systolic pressure (PASP) >60 mmHg by echo Doppler (unless right heart catheterization [RHC] demonstrates PASP ≤60mmHg); in case RHC is performed, PASP >2/3 systemic BP with PVR >5 Wood units after vasodilator challenge, in the absence of symptomatic hypotension or systolic BP <90 mmHg.
- •Evidence of intracardiac mass, thrombus, or vegetation.
- •Ebstein Anomaly or congenital right ventricular dysplasia.
- •Surgical or interventional correction is indicated for other concomitant valvular diseases (subjects with concomitant valvular disease may treat their respective valve first and wait 30 days before being reassessed for the trial).
- •Subjects with valve prostheses implanted in the tricuspid valve.
- •Pre-existing prosthetic valve(s) (other than tricuspid ones) with clinically significant prosthetic dysfunction.
- •Active infection, infective endocarditis or sepsis within 3 months, or infections requiring antibiotics treatment within two weeks prior to planned procedure.
- •Untreated clinically significant coronary artery disease requiring revascularization.
- •Acute myocardial infarction or unstable ischemia-related angina within 30 days prior to the planned procedure.
- •Any percutaneous coronary, intracardiac or carotid intervention within 30 days prior to the planned procedure.
- •Cerebrovascular stroke (ischemic or bleeding) within 3 months prior to enrollment.
- •Active peptic ulcer or active gastrointestinal bleeding within 3 months prior to enrollment.
- •Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis, or coagulopathy.
- •Inability to tolerate anticoagulation or antiplatelet therapy.
- •Renal insufficiency (eGFR< 30ml/min [per the CKD-EPI formula] and/or renal replacement therapy).
- •Patients with hepatic insufficiency or cirrhosis with Child-Pugh score class C
- •Pregnancy or intent to become pregnant.
- •Severe Chronic Obstructive Pulmonary Disease requiring steroids or requiring continuous home oxygen.
- •Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, or contrast media.
- •Estimated life expectancy <12 months.
- •Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.
- •Subjects with current history of illicit drug use.
- •Any other condition making it unlikely the patient will be able to complete all protocol procedure and follow-ups determined by the investigator.
研究组 & 干预措施
Single-arm cohort ("Not Suitable for Conventional TTVI"cohort): LuX-Valve
干预措施: TTVI with LuX-Valve Plus System (Device)
Randomized cohort (EVOQUE Eligible Cohort): LuX-Valve
干预措施: TTVI with LuX-Valve Plus System (Device)
Randomized cohort (EVOQUE Eligible Cohort): EVOQUE
干预措施: TTVI with EVOQUE (Device)
结局指标
主要结局
Rate of Major Adverse Events (MAE)
时间窗: 30 Day Post-Procedure
Rate of Major Adverse Events (MAE) at 30 days consisting of the following components: * Cardiovascular Mortality * Myocardial Infarction (MI), periprocedural and spontaneous * All Stroke, disabling and non-disabling * New need for renal replacement therapy * Severe bleeding (includes type 3b or higher as defined by Tricuspid Valve Academic Research Consortium \[TVARC\] * Non-elective tricuspid valve re-intervention, surgery or transcatheter * Major access site and vascular complications * Major cardiac structural complications * Device-related pulmonary embolism * Arrhythmia and conduction disorders requiring permanent pacing
Rate of Composite Clinical Success
时间窗: 12 Months Post-Procedure
Percentage (%) of participants achieving composite clinical success at 12 months. Composite clinical success is defined as meeting all of the following criteria: Patient survival, Free from heart failure hospitalization, No tricuspid valve surgery or percutaneous intervention
Hierarchical composite endpoint: All-cause mortality, Heart failure hospitalization, and Tricuspid valve surgery or percutaneous intervention
时间窗: 12 Months Post-Procedure
Comparison of number of wins with composite endpoint events or improvement between experimental and active comparator arms
次要结局
未报告次要终点