Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 8
- 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 CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.
详细描述
This is a non-randomized, prospective, multi-center safety and device success study. 34 patients have been enrolled at 4 participating investigational centers in Europe. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, discharge, 30 days, 6 months, 1 year and annually thereafter through 5 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High surgical risk: STS Score ≥ 8,EuroSCORE ≥
- •Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
- •Study patient is an adult of legal consent age.
- •Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.
排除标准
- •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).
研究组 & 干预措施
TAVR
with CENTERA self-expanding valve
干预措施: Edwards CENTERA Self-Expanding Transcatheter Heart Valve (Device)
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
- device success(1 year)