Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 34
- 主要终点
- All-cause mortality rate
研究概览
简要总结
The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.
详细描述
This is a non-randomized, prospective, multicenter safety and device success study. Two hundred fifty (250) patients are planned to be enrolled at up to 20 participating investigational centers in Europe and Canada. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, hospital discharge, 30 days, 1 year and annually thereafter for a minimum of 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe symptomatic calcific aortic valve stenosis with:
- •High surgical risk: STS Score ≥ 8 or EuroSCORE ≥ 15 (first 50 patients),
- •High to Intermediate surgical risk: STS Score ≥ 4 or EuroSCORE ≥ 10 (patients 51 to 150).
- •Intermediate surgical risk: STS Score 4 to 8 or Logistic EuroSCORE 10 to 15 (subsequent patients); except for 20mm valve implants (STS Score > 4 or EuroSCORE ≥ 10).
- •Age ≥ 75 years
- •Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
- •Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.
排除标准
- •Non-calcified aortic valve
- •Acute myocardial infarction ≤ 30 days before the intended treatment
- •Untreated clinically significant coronary artery disease requiring revascularization.
- •Aortic valve is a congenital unicuspid or congenital bicuspid valve.
- •Mixed aortic valve disease (with predominant aortic regurgitation)
- •Preexisting bioprosthetic valve or ring in any position
- •For Intermediate Risk patients enrolled under inclusion criterion 1.c) patients with untreated pre-existing conduction disturbances (AV Block and Bundle Branch Block).
结局指标
主要结局
All-cause mortality rate
时间窗: 30 days post-index procedure
NAP
次要结局
- safety endpoints(VARC II)(Discharge or 72 hours (whichever is longer), 30 days, 1 and 5 years post-index procedure.)