NCT02615431Unknown不适用
the Influence of MitraClip on Apnoea Asleep
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Apnoea-Hypopnoea-Index
研究概览
简要总结
The aim of the present study is to influence the central and obstructive sleep apnoea in patients with severe mitral insufficiency by an interventional MitraClip examination to evaluate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patient suffer on severe symptomatical mitral insufficience
- •male and female patients is planned an interventional MitraClip examination
- •Dyspnea with a NYHA (New York Heart Association) II - III
- •an high logistic Euro-Score (> 20)
- •no execution of surgical intervention because of relevant comorbidities
排除标准
- •younger than 18 years
- •pregnancy and breast-feeding
- •persons without mental ability of capacity to understand and follow the instructions of the investigator
- •persons in dependence from the sponsor or working with the sponsor
- •participation in other studies
结局指标
主要结局
Apnoea-Hypopnoea-Index
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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