NCT01238835已完成不适用
Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)
Edwards Lifesciences40 个研究点 分布在 4 个国家目标入组 220 人开始时间: 2009年9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
- 220
- 试验地点
- 40
- 主要终点
- Number of Deaths
研究概览
简要总结
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery system, and crimper accessories.
详细描述
Purpose: The purpose of this trial is to evaluate the acute safety and effectiveness of the SAPIEN XT™ study valve and next generation Ascendra™ delivery components.
Follow-up Intervals: Subject data collection will include clinical information at baseline and during the index procedure. Subjects will undergo clinical follow-up at discharge, 30 days, 6 month annually for 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
- •EuroSCORE of ≥ 15 %
- •Severe senile degenerative aortic valve stenosis
- •Symptomatic aortic valve stenosis
- •Informed consent
排除标准
- •Logistic Euroscore > 40 %
- •Evidence of an acute myocardial infarction
- •Congenital unicuspid or congenital bicuspid valve/ non-calcified
- •Mixed aortic valve disease
结局指标
主要结局
Number of Deaths
时间窗: 30 days
Number of death at 30-days from the index procedure.
次要结局
- Number of Participants With a Stroke(30-days)
研究者
研究点 (40)
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