NCT04009434Unknown不适用
Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 1,162
- 试验地点
- 2
- 主要终点
- Death from any cause and heart failure hospitalization
研究概览
简要总结
To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve disease as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Death from any cause and heart failure hospitalization
时间窗: 1 year
Composite endpoint of time to heart failure hospitalization or death from any cause
次要结局
- 6 Minute Walk Test(1 year)
- Death from any cause(1, 2, 3, 4 years)
- Need for mitral valve reintervention(1, 2, 3, 4 years)
- Mitral regurgitation severity(1 year)
- New York Heart Association Functional Class(1, 3, 6 months and 1, 2, 3, 4 years)
研究者
研究点 (2)
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