Edwards SAPIEN 3 Aortic Bioprosthesis Multi-Region Outcome Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,000
- 试验地点
- 73
- 主要终点
- All cause mortality
研究概览
简要总结
This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites.
300 patients out of the 2000 patients enrolled in the main registry are planned to be consecutively enrolled in a select few sites for studying the valve performance. Echocardiogram and angiogram will be taken routinely.
详细描述
The purpose of this registry is to provide clinical outcome and safety information on patients that will be treated with the Edwards SAPIEN 3 Transcatheter Heart Valve and delivery devices for severe, symptomatic calcific aortic stenosis. In addition, the information collected will serve post market safety and surveillance regulatory obligations.
Consecutive patient data will be collected at baseline, procedure, discharge, after discharge (at approx. 30 days post-index procedure), 12 months post-index procedure and annually thereafter up to 5 years post-implant according to usual practice at site.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffering from severe, symptomatic, calcific aortic stenosis
- •STS Score ≥ 8
- •Logistic EuroSCORE ≥15
排除标准
- •Congenital unicuspid or congenital bicuspid aortic valve
- •Evidence of intracardiac mass, thrombus or vegetation
- •Active infection or endocarditis
结局指标
主要结局
All cause mortality
时间窗: 30 days
次要结局
未报告次要终点