SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,103
- 试验地点
- 92
- 主要终点
- Mortality, Disabling Stroke or Heart Failure Rehospitalization
研究概览
简要总结
The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis.
Additionally, a stress echocardiography sub-study will be conducted as part of the SMART Trial at select sites. The purpose of the sub-study is to evaluate performance of SE versus BE TAVR in subjects with a small aortic annulus and symptomatic severe native aortic stenosis after undergoing exercise stress echocardiographic testing.
详细描述
This is a prospective, multi-center, international, randomized controlled, post-market trial.
The primary objectives of the trial are to demonstrate clinical non-inferiority and hemodynamic superiority of the Evolut PRO/PRO+/FX System when compared to subjects treated with the SAPIEN 3/3 Ultra System at 12 months post-procedure.
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE Transcatheter Aortic Valve (TAV) or an Edwards BE Transcatheter Heart Valve (THV). Data will be collected at pre- and post-procedure, at discharge, at 30 days, and once a year until the 5-year follow-up is completed.
Product Names:
- Medtronic Evolut PRO and Evolut PRO+ TAV Systems, Evolut FX System (Commercially available in the United States and may be used upon commercial availability in Canada.)
- Edwards SAPIEN 3 and SAPIEN 3 Ultra THV Systems
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
- •Heart Team agrees that the subject is deemed symptomatic and is a candidate for transcatheter aortic valve replacement (TAVR)
- •Subject has a predicted risk of operative mortality < 15% as determined by the local Heart Team
- •Subject has severe aortic stenosis as determined by transthoracic echocardiography (TTE) at rest
- •Subject has a small aortic annulus as determined by Multi-detector computed tomography (MDCT)
- •Subject's anatomy is appropriate for both Medtronic Evolut PRO/PRO+/FX TAV and Edwards SAPIEN 3/3 Ultra TAV
- •Subject's anatomy is suitable for TAVR via transfemoral vessel access
- •Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
排除标准
- •Estimated life expectancy of fewer than 2 years
- •Multivessel coronary artery disease with a Syntax score >32 and/or unprotected left main coronary artery(Syntax score calculation is not required for patients with history of previous revascularization if repeat revascularization is not planned).
- •Participating in another trial that may influence the outcome of this trial
- •Need for an emergent procedure for any reason
- •Contraindicated for treatment with the Evolut PRO/PRO+/FX and Edwards SAPIEN 3/3 Ultra TAV in accordance with the Instructions for Use
- •Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams
- •Pregnant, nursing, or planning to be pregnant
- •Subject is less than the legal age of consent, legally incompetent, unable to provide his/her own informed consent, or otherwise vulnerable
- •Subject has an active COVID-19 infection or relevant history of COVID-19
- •Previous aortic valve replacement
研究组 & 干预措施
Medtronic Self-Expanding TAV
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
干预措施: Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems (Device)
Edwards Balloon-Expandable THV
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
干预措施: Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems (Device)
结局指标
主要结局
Mortality, Disabling Stroke or Heart Failure Rehospitalization
时间窗: 12 months
Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization.
Bioprosthetic Valve Dysfunction (BVD)
时间窗: 12 months
Percentage of participants with BVD as determined by echocardiography (hemodynamic structural valve dysfunction (aortic valve no longer works properly as measured by hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch (valve is too small) and/or ≥ moderate total aortic regurgitation (backward flow of blood)), thrombosis (formation of a blood clot), endocarditis (inflammation of the endocardium - the inner lining of the heart chambers and valves), or aortic valve re-intervention (a follow-up procedure to fix or replace the aortic prosthetic valve))
次要结局
- Percentage of Participants With Hemodynamic Structural Valve Dysfunction (HSVD)(12 months)
- Hemodynamic Mean Gradient as Continuous Variable(12 months)
- Effective Orifice Area (EOA) as a Continuous Variable(12 months)
- Rate of Moderate or Severe Prothesis-patient Mismatch (PPM)(30 days)
- Percentage of Participants With BVD in Female Subjects(12 months)