NCT05436028已完成不适用
TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System in Patients With Severe or Greater Tricuspid Regurgitation -- SafetY and Clinical Performance
Jenscare Scientific2 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2023年5月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure
研究概览
简要总结
This is a prospective, single-arm, multi-center trial to evaluate the LuX-Valve Plus system for treating symptomatic at least severe TR in patients who are deemed high risk for tricuspid surgery.
Treatment with the LuX-Valve Plus system may enable patients with tricuspid regurgitation to have a complete tricuspid valve replacement with a minimally invasive approach.
Up to 150 subjects will be implanted at up to 24 institutions worldwide. No single institution will be allowed to register more than 25% of total subjects. There is no minimum number of subjects to be registered at any site.
Up to3 per site, may be implanted by operators without prior experience using the LuX-Valve Plus device to gain hands-on experience.Each site has a maximum of 3 roll-in cases. The data of roll-in subjects will not count towards the overall enrollment cap. Safety and performance results of roll-in subjects will be analyzed in subgroups.
All subjects will be evaluated at baseline, procedure, discharge, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥50 years at time of consent
- •Severe or greater TR (≥3+) assessed on transthoracic echocardiography by Echo Core Lab (ECL) using a 5-grade classification
- •New York Heart Association (NYHA) Class II-IV
- •In the judgment of the Site Heart Team, the subject has been adequately treated per applicable standards, including optimal medical therapy with diuretics
- •The Site Heart Team concur the benefit-risk analysis supports transcatheter tricuspid valve replacement per current guidelines for the management of valvular heart disease, and the subject is at high risk for tricuspid valve surgery.
- •Patient must be able to fully understand all aspects of the investigation that are relevant to the decision to participate, and provide a written informed consent
- •In France, patient is affiliated to a health social security regimen or equivalent
排除标准
- •Pulmonary arterial systolic pressure (PASP) > 60 mmHg by echo Doppler (unless right heart catheterization [RHC] demonstrates PASP ≤60 mmHg) or R heart catheterization OR PASP > 2/3 systemic BP with PVR > 5 Wood units after vasodilator challenge, in the absence of symptomatic hypotension or systolic BP < 90 mmHg.
- •Left Ventricular Ejection Fraction (LVEF) <35%
- •Evidence of intracardiac mass, thrombus or vegetation
- •Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT
- •Ebstein Anomaly or congenital right ventricular dysplasia
- •Surgical correction is indicated for other concomitant valvular disease (e.g., severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation) Subjects with concomitant valvular disease may treat their respective valve first, and wait 2 months before being reassessed for the trial.
- •Patients with valve prostheses implanted in the tricuspid valve
- •Pre-existing prosthetic valve(s) (other than tricuspid ones) with clinically significant prosthetic dysfunction
- •Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the 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 prior 3 months to enrollment
- •Active peptic ulcer or active gastrointestinal (GI) bleeding within prior 3 months to enrollment
- •Inability to tolerate anticoagulation or antiplatelet therapy
- •Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
- •Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy at the time of screening
- •Chronic liver failure or cirrhosis with MELD-Albumin Score ≥ 12
- •Severe lung disease or patient dependent on home oxygen and deemed unsuitable by the local heart team or eligibility committee for the study.
- •Futility with 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.
- •Pregnant or lactating; or female of childbearing potential with a positive pregnancy test within 14 days prior to intervention (contraceptive requirement is shown in Appendix XI)
- •Allergic to one or more of the substances contained in the implant and/or delivery system, including nitinol, tantalum, PET, PTFE, bovine pericardium, Pebax, PA, Polyurethane, Stainless steel.
结局指标
主要结局
A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure
时间窗: 30 days post procedure
A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure, as listed below: Cardiovascular Mortality Myocardial Infarction (MI) Stroke New onset renal failure requiring unplanned dialysis or renal replacement therapy Severe Bleeding (includes fatal, life-threatening and extensive bleeding as defined by MVARC) Non-selective tricuspid valve surgery or transcatheter re-intervention post procedure Major cardiac structural complications Major access site and vascular complications Device-related pulmonary embolism New pacemaker implantation due to AV block
次要结局
- Acute Secondary Endpoints-Procedural Success Rate(7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure)
- Clinical and Functional Endpoints-All-cause mortality(at 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Clinical and Functional Endpoints-NYHA Functional Class(at 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Echocardiographic Endpoints-TR Severity Grade(at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Echocardiographic Endpoints-Regurgitant Volume(at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Echocardiographic Endpoints-Mean Tricuspid valve inflow gradient(at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Echocardiographic Endpoints-Right Atrial Volume(at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Echocardiographic Endpoints-Right ventricular functions assessments:fractional area change（FAC）(at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Acute Secondary Endpoints-Clinical Success Rate at 30 days(at 30 days)
- Clinical and Functional Endpoints-Heart failure hospitalization(at 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Clinical and Functional Endpoints-Distance of 6-Minute Walk Test (6MWT)(at 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Echocardiographic Endpoints-Vena Contracta Width(at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Echocardiographic Endpoints-Effective Regurgitant Orifice Area (EROA)(at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Acute Secondary Endpoints-Device Success Rate(From the first skin incision for the investigational device to the time patient's exist from OR/Cath lab,assessed up to 24 hours post procedure.)
- Clinical and Functional Endpoints-Cardiovascular mortality(at 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Echocardiographic Endpoints-Regurgitation Jet Area(at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Echocardiographic Endpoints-Right ventricular functions assessments:TAPSE(at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Echocardiographic Endpoints-Right ventricular functions assessments:systolic tricuspid lateral annular tissue velocity S'(at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Echocardiographic Endpoints-Left Ventricular Ejection Fraction (LVEF)(at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Clinical and Functional Endpoints-Tricuspid valve surgery or transcatheter re-intervention(at 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Clinical and Functional Endpoints-Kansas City Cardiomyopathy Questionnaire (KCCQ)(at 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Clinical and Functional Endpoints-Edema assessment(at 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Echocardiographic Endpoints-Right ventricular functions assessments:Hepatic vein flow reversal(at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Echocardiographic Endpoints-Cardiac Output(at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Echocardiographic Endpoints-Paravalvular leak severity(at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Echocardiographic Endpoints-Systolic pulmonary artery pressure(at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure)
- Echocardiographic Endpoints-Right ventricular functions assessments:Inferior Cava Vein Diameter/respiratory variations(at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure)
研究者
研究点 (2)
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