ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)
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
- 17
- 主要终点
- Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant
研究概览
简要总结
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to provide safety surveillance of the device.
详细描述
A single arm, prospective, multicenter, non-randomized and open registry up to 1 Year Follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where surgical aortic valve replacement (SAVR) via open surgery is considered to be associated with high surgical risk for evaluating the safety and performance of the implantation and the safety at 30-Day Follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 has severe aortic stenosis
- •Native aortic annulus diameter from ≥ 21mm up to ≤ 27mm
- •Patient willing to participate in the study and provides signed EC-approved informed consent
- •The subject and treating physician agree the subject will return for all required post-procedure follow-up visits
排除标准
- •Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE TA™ and Delivery System as per the Instructions For Use.
结局指标
主要结局
Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant
时间窗: 30 days and 12 Months Follow-up
Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant . MACCE defined as All cause mortality, Re-intervention, Myocardial Infarction, or Stroke.
次要结局
- Device success at 30 days and 12 Months follow-up(30 days and 12 Months follow-up)
- Procedural Success post-implantation (up to 24 hours after device implantation)(Post-Implantation (up to 24 hours after device implantation))