NCT02675114进行中（未招募）不适用
A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
Edwards Lifesciences77 个研究点 分布在 2 个国家目标入组 1,000 人开始时间: 2016年3月1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
- 1,000
- 试验地点
- 77
- 主要终点
- All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure)
研究概览
简要总结
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
详细描述
Prospective, randomized, controlled, multi-center trial. Patients having an operative mortality < 4% (low operative risk) for surgical aortic valve replacement will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 10 years.
A subset of PARTNER 3 randomized patients will be enrolled in the Actigraphy/Quality of Life. Additional patients will be enrolled in either the Bicuspid Registry, Underrepresented Populations Registry (UPR) or the Alternative Access Registry.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe, calcific aortic stenosis
- •New York Heart Association Functional Class ≥ 2 OR exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR asymptomatic with Left Ventricular Ejection Fraction (LVEF) <50%
- •Heart team agrees the patient has a risk of operative mortality and has an Society of Thoracic Surgeons (STS) score < 4
- •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
- •Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm transcatheter heart valve
- •Iliofemoral vessel characteristics that would preclude safe passage of the introducer sheath
- •Evidence of an acute myocardial infarction ≤ 30 days before randomization
- •Aortic valve is unicuspid, bicuspid, or non-calcified
- •Severe aortic regurgitation (>3+)
- •Severe mitral regurgitation (>3+) ≥ moderate stenosis
- •Pre-existing mechanical or bioprosthetic valve in any position
- •Complex coronary artery disease:
- •Unprotected left main coronary artery
- •Syntax score > 32
- •Heart Team assessment that optimal revascularization cannot be performed
- •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
- •Ventricular dysfunction with LVEF < 30%
- •Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- •Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
- •Stroke or transient ischemic attack within 90 days of randomization
- •Renal insufficiency and/or renal replacement therapy at the time of screening.
- •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 or cannulation and aortotomy for surgical aortic valve replacement
- •Hostile chest or conditions or complications from prior surgery that would preclude safe reoperation
- •Patient refuses blood products
- •Body mass index > 50 kg/m2
- •Estimated life expectancy < 24 months
- •Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
- •Immobility that would prevent completion of study procedures
- •Patient is not a candidate for both arms of the study
- •Currently participating in an investigational drug or another device study.
结局指标
主要结局
All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure)
时间窗: 1 year
Number of patients that had any of these events
次要结局
- Death, Kansas City Cardiomyopathy Questionnaire (KCCQ) Score < 45 or KCCQ Score Decrease ≥ 10 Points(30 days)
- New Onset Atrial Fibrillation(30 days)
- All Stroke(30 days)
- Length of Index Hospitalization(Discharge (expected average of 7 days))
- Death or Stroke(30 days)
研究者
研究点 (77)
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