NCT02458560已完成不适用
Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
Edwards Lifesciences54 个研究点 分布在 9 个国家目标入组 203 人开始时间: 2015年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 54
- 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 symptomatic adult patients with severe aortic stenosis.
详细描述
This is a non-randomized, prospective, multi-center safety and device success study. Up to two hundred (200) patients are planned to be implanted at up to 35 participating investigational centers in Europe, Australia and New Zealand. 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart team (including cardiac surgeon) agrees on eligibility including as-sessment that TAVI is appropriate.
- •High surgical risk: 8 ≤ STS Score ≤ 15 or 15 ≤ Logistic EuroSCORE I ≤
- •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).
结局指标
主要结局
All-cause mortality rate
时间窗: 30 days post-index procedure
次要结局
- Safety composite of mortality, stroke, major vascular, complication, life-threatening bleeding, acute kidney injury coronary artery obstruction requiring intervention, and THV-related dysfunction requiring repeat procedure.(30 days)
研究者
研究点 (54)
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