NCT03042104进行中（未招募）不适用
Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
Edwards Lifesciences151 个研究点 分布在 1 个国家目标入组 901 人开始时间: 2017年7月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 901
- 试验地点
- 151
- 主要终点
- All-cause death, all stroke, and unplanned cardiovascular hospitalization
研究概览
简要总结
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
详细描述
This is a prospective, randomized, controlled, multicenter study. Patients will be randomized to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 / SAPIEN 3 Ultra THV or clinical surveillance. Patients will be stratified by whether they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.
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
- •65 years of age or older
- •Severe aortic stenosis
- •Patient is asymptomatic
- •LV ejection fraction ≥ 50%
- •Society of Thoracic Surgeons (STS) risk score ≤ 10
- •The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
排除标准
- •Patient is symptomatic
- •Patient has any concomitant valvular, aortic, coronary artery disease requiring surgery making AVR a Class I indication.
- •Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV
- •Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
- •Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post TAVR
- •Evidence of an acute myocardial infarction ≤ 30 days before randomization
- •Aortic valve is unicuspid, bicuspid with unfavorable features for TAVR, or is non-calcified
- •Severe aortic regurgitation (>3+)
- •Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis
- •Pre-existing mechanical or bioprosthetic valve in any position
- •Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of randomization
- •Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states
- •Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization
- •Hypertrophic cardiomyopathy with obstruction
- •Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- •Inability to tolerate or condition precluding treatment with anti-thrombotic therapy
- •Stroke or transient ischemic attack within 90 days of randomization
- •Renal insufficiency and/or renal replacement therapy
- •Active bacterial endocarditis within 180 days of randomization
- •Severe lung disease or currently on home oxygen
- •Severe pulmonary hypertension
- •History of cirrhosis or any active liver disease
- •Significant frailty as determined by the Heart Team
- •Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system
- •Patient refuses blood products
- •BMI >50 kg/m2
- •Estimated life expectancy <24 months
- •Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
- •Currently participating in an investigational drug or another device study.
- •Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
结局指标
主要结局
All-cause death, all stroke, and unplanned cardiovascular hospitalization
时间窗: When all patients have reached 2-year follow-up
The number of patients that have any of these conditions
次要结局
- Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥75 and 3) KCCQ decrease ≤10 points(2 years)
- Left Ventricular Health(2 years)
- Change in Left Ventricular Ejection Fraction (LVEF)(2 years)
- New onset atrial fibrillation(When all patients have reached 2-year follow-up)
- Death or disabling stroke(When all patients have reached 2-year follow-up)
研究者
研究点 (151)
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