Symetis ACURATE TA™ Valve Implantation Using TransApical Access:SAVI2 Registry
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
- 27
- 主要终点
- Rate of all-cause mortality at 30 days follow-up
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 collect continued surveillance data pertaining to safety and performance of the device.
详细描述
The SAVI2 registry is a single arm, prospective, multicenter, non-randomized and open registry up to 1 year follow-up with the Symetis ACURATE TA™.
The ACURATE TA™ is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open surgery is considered to be associated with high surgical risk.
The primary objectives of the registry is to further evaluate 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 all-cause mortality at 30 days follow-up
时间窗: 30-Day Follow-up
Rate of all-cause mortality at 30 days follow-up
次要结局
- Device success at 7 Day or Discharge (which ever comes first) and at 12 months follow-up(7-Days Follow-up and 12-Months Follow-up)
- Rate of clinical endpoints (VARC II) at 30 days and 12 months(30-Days and 12 Months Follow-up)
- Functional improvement from baseline as per NYHA Functional Classification at 30 days and 12 months(30-Day and 12-Month Follow-up)
- Procedural success post-implant(Procedure to 24h Post-implantation)