Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,070
- 试验地点
- 62
- 主要终点
- Randomized Cohort: Tricuspid Regurgitation (TR) grade reduction
研究概览
简要总结
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
详细描述
The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Despite medical therapy (OMT) per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR. Patient must be on OMT per the local heart team at the time of TR assessment for trial eligibility (TTE). OMT includes stable oral diuretic medications, unless patient has a documented history of intolerance.
- •Functional and/or degenerative TR graded as at least severe on a transthoracic echocardiogram (assessed by the echo core lab using a 5-grade classification)
- •The Local Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement
- •Patient is willing and able to comply with all study evaluations and provides written informed consent.
排除标准
- •Anatomy precluding proper device delivery, deployment and/or function
- •LVEF < 25%
- •Evidence of severe right ventricular dysfunction
- •Any of the following pulmonary pressure parameters:
- •PASP >60 mmHg by echo Doppler (unless RHC demonstrates PASP ≤70 mmHg)
- •PASP >70 mmHg by RHC
- •PVR >5 Wood units by RHC (unless PVR ≤5 Wood units and systolic BP >85 mmHg after vasodilator challenge)
- •Previous tricuspid surgery or intervention
- •Presence of trans-tricuspid pacemaker or defibrillator lead with any of the following:
- •Implanted in the RV within the last90 days
- •Patient is pacemaker dependent5 on trans-tricuspid lead without alternative pacing option
- •Has delivered appropriate ICD therapy
- •Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation.
- •Active endocarditis within the last 90 days or infection requiring antibiotic therapy (oral or intravenous) within the last 14 days
- •Hemodynamically significant pericardial effusion
- •Significant intra-cardiac mass, thrombus, or vegetation.
- •Clinically significant, untreated coronary artery disease requiring revascularization, evidence of acute coronary syndrome, recent myocardial infarction within the last 30 days.
- •Any of the following cardiovascular procedures:
- •Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days
- •Carotid surgery within the last 30 days
- •Direct current cardioversion within the last 30 days
- •Leadless RV pacemaker implant within the last 30 days
- •Cardiac surgery within the last 90 days
- •Known history of untreated severe symptomatic carotid stenosis (>50% by ultrasound) or asymptomatic carotid stenosis (>70% by ultrasound)
- •Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365days), or any planned percutaneous cardiac procedure within the next 90 days
- •Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or hemodynamic support within the last 30 days
- •Patient with refractory heart failure requiring or which required advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/AHA/ESC/EACTS Stage D heart failure)
- •Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 6 months (180 days)
- •Stroke within the last 90 days
- •Modified Rankin Scale ≥ 4 disability
- •Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 25 mL/min/1.73m2 or requiring chronic renal replacement therapy.
- •Patients with hepatic insufficiency or cirrhosis with Child-Pugh score class C
- •Patient is oxygen-dependent or requires continuous home oxygen
- •Chronic anemia with transfusion dependency or Hgb < 9 g/dL not corrected by transfusion
- •Unable to walk at least 100 meters in a 6-minute walk test
- •Thrombocytopenia (Platelet count < 75,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3)
- •Known bleeding or clotting disorders or patient refuses blood transfusion
- •Active gastrointestinal (GI) bleeding within the last 90 days
- •Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days).
- •Patients in whom (any of the following):
- •TEE is contraindicated or cannot be completed
- •tricuspid valve anatomy is not evaluable by TTE or TEE
- •In the opinion of the investigator, access to and through the femoral vein/IVC with a guide sheath and delivery catheter is deemed not feasible (e.g. occluded femoral veins, occluded or thrombosed IVC filter)
- •Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, or contrast media
- •Currently participating in another investigational biologic, drug or device study
- •Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months (365 days).
- •Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid, amyloidosis, sarcoidosis, hemochromatosis) or significant uncorrected congenital heart disease (including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV)
- •Any condition, in the opinion of the investigator, making it unlikely the patient will be able to complete all protocol procedures and follow-ups
- •Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship
- •Any patient considered to be vulnerable
研究组 & 干预措施
Edwards EVOQUE System & OMT
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation
干预措施: Edwards EVOQUE System (Device)
Optimal Medical Therapy (OMT)
Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
干预措施: Optimal Medical Therapy (Drug)
Single-Arm Registry
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization
干预措施: Edwards EVOQUE System (Device)
Continued Access Study
Provides continued access to transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation.
干预措施: Edwards EVOQUE System (Device)
结局指标
主要结局
Randomized Cohort: Tricuspid Regurgitation (TR) grade reduction
时间窗: 6 months
Comparison of number of participants with reduction in TR between experimental and active comparator arms. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better.
Randomized Cohort: Hierarchical composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement
时间窗: 6 months
Comparison of number of wins with composite endpoint event improvement between experimental and active comparator arms
Randomized Cohort: Rate of Major Adverse Events (MAE)
时间窗: 30 days
Rate of Major Adverse Events (MAE) in experimental arm (Edwards EVOQUE System \& OMT)
Randomized Cohort: Hierarchical composite endpoint: all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improvement, and 6MWD improvement
时间窗: 1 year
Comparison of number of wins with composite endpoint events or improvement between experimental and active comparator arms
Continued Access Study: Rate of Major Adverse Events (MAE)
时间窗: 30 days
Rate of MAEs in the Continued Access Study arm
Continued Access Study: Tricuspid Regurgitation (TR) grade reduction to moderate, mild, or none/trace
时间窗: 6 months
TR grade reduction to moderate, mild, or none/trace from baseline. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential); Lower grades of TR are better.
Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
时间窗: 1 year
Improvement in QOL (by KCCQ overall summary score) of at least 10 points. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better QOL.
Continued Access Study: New York Heart Association (NYHA) functional class
时间窗: 1 year
NYHA functional class improvement of at least 1 class. NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).
Continued Access Study: 6MWD
时间窗: 1 year
6MWD improvement of at least 30 meters
Continued Access Study: All-cause mortality
时间窗: 1 year
Deaths from any cause
Continued Access Study: Durable right ventricular assist device (RVAD) implantation or heart transplant
时间窗: 1 year
Durable RVAD implantation or heart transplant
Continued Access Study: Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention
时间窗: 1 year
Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention.
Continued Access Study: Annualized rate of heart failure hospitalizations
时间窗: 1 year
Annualized rate of heart failure hospitalizations
次要结局
- Continued Access Study: Need for paracentesis(1 year, annually through 5 years)
- Randomized cohort: Tricuspid Regurgitation (TR) grade reduction(Time Frame: Discharge (assessed up to 7 days post procedure))
- Randomized cohort: All-Cause Mortality(1 year, annually through 5 years)
- Randomized cohort: Heart failure hospitalizations(1 year, annually through 5 years)
- Randomized cohort: Non-elective tricuspid valve re-intervention (percutaneous or surgical)(1 year, annually through 5 years)
- Randomized cohort: Durable RVAD implantation or heart transplant(1 year, annually through 5 years)
- Randomized cohort: Need for paracentesis(1 year, annually through 5 years)
- Randomized cohort: Reduction in TR grade by at least one grade(1 year)
- Randomized cohort: Reduction in New York Heart Association (NYHA) functional class by at least one grade(1 year)
- Randomized cohort: Change in Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline(1 year)
- Randomized cohort: Death and heart failure hospitalization(1 year)
- Randomized cohort: All-cause hospitalizations(1 year)
- Randomized cohort: All-cause mortality(1 year)
- Randomized cohort: Change in 6MWD from baseline(1 year)
- Roll-in cohort: Tricuspid Regurgitation (TR) grade reduction(Time Frame: Discharge (assessed up to 7 days post procedure))
- Roll-in cohort: All-cause mortality(1 year)
- Roll-in cohort: Heart failure hospitalizations(1 year, annually through 5 years)
- Roll-in cohort: Non-elective tricuspid valve re-intervention (percutaneous or surgical)(1 year, annually through 5 years)
- Roll-in cohort: Durable RVAD implantation or heart transplant(1 year, annually through 5 years)
- Roll-in cohort: Need for paracentesis(1 year, annually through 5 years)
- Roll-in cohort: Reduction in tricuspid regurgitation (TR) grade by at least one grade(1 year)
- Roll-in cohort: Reduction in New York Heart Association (NYHA) functional class by at least one grade(1 year)
- Roll-in cohort: Change in Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline(1 year)
- Roll-in cohort: Death and heart failure hospitalization(1 year)
- Roll-in cohort: All-cause hospitalizations(1 year)
- Roll-in cohort: Change in 6MWD from baseline(1 year)
- Registry cohort: Tricuspid Regurgitation (TR) grade reduction(Time Frame: Discharge (assessed up to 7 days post procedure))
- Registry cohort: All-cause mortality(1 year)
- Registry cohort: Heart failure hospitalizations(1 year, annually through 5 years)
- Registry cohort: Change in 6MWD from baseline(1 year)
- Registry cohort: Non-elective tricuspid valve re-intervention (percutaneous or surgical)(1 year, annually through 5 years)
- Registry cohort: Durable RVAD implantation or heart transplant(1 year, annually through 5 years)
- Registry cohort: Need for paracentesis(1 year, annually through 5 years)
- Registry cohort: Reduction in TR grade by at least one grade(1 year)
- Registry cohort: Reduction in New York Heart Association (NYHA) functional class by at least one grade(1 year)
- Registry cohort: Change in Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline(1 year)
- Registry cohort: Death and heart failure hospitalization(1 year)
- Registry cohort: All-cause hospitalizations(1 year)
- Continued Access Study: Tricuspid Regurgitation (TR) grade reduction(Time Frame: Discharge (assessed up to 7 days post procedure))
- Continued Access Study: All-cause mortality(1 year, annually through 5 years)
- Continued Access Study: Heart failure hospitalizations(1 year, annually through 5 years)
- Continued Access Study: Non-elective tricuspid valve re-intervention (percutaneous or surgical)(1 year, annually through 5 years)
- Continued Access Study: Durable RVAD implantation or heart transplant(1 year, annually through 5 years)