NCT02033811招募中不适用
MitraClip® Registry - an Observational Study of Percutaneous Mitral Valve Repair Using the MitraClip® System
Klinik für Kardiologie, Pneumologie und Angiologie1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Major cardiac adverse events
研究概览
简要总结
Percutaneous mitral valve repair with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair (PMVR) in high risk patients.
The aim of this registry is to collect prospectively and systematically clinical research data from patients undergoing PMVR with the MitraClip® system. This registry is an open-end observational study to assess the characteristics and outcomes patients with severe mitral regurgitation undergoing PMVR.
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
- •severe mitral regurgitation
- •percutaneous mitral valve repair (PMVR) with the MitraClip® system
排除标准
- •< 18 years
- •Patients considered by the heart team to be unlikely to receive meaningful or durable clinical benefit from the procedure
结局指标
主要结局
Major cardiac adverse events
时间窗: 30 days
increase in the 30-day risk of adverse events among patients receiving PMVR
次要结局
- Mortality(1 year)
研究者
Klinik für Kardiologie, Pneumologie und Angiologie
Director Division of Cardiology, Pulmonary Disease and Vascular Medicine
Heinrich-Heine University, Duesseldorf
研究点 (1)
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