NCT04393779终止不适用
Beating Heart Mitral Valve REPair With the HARPOON™ System: ReaL World Outcomes From a multICenter observATional European Registry
Edwards Lifesciences14 个研究点 分布在 3 个国家目标入组 26 人开始时间: 2020年10月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 14
- 主要终点
- Freedom From Re-operation Due to Recurrent Severe Mitral Regurgitation Through 1-year Post-implant
研究概览
简要总结
To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.
详细描述
This is a single arm, prospective, multicenter, post-market, observational registry that will evaluate subjects for up to 5 years post treatment.
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
- •Subjects who are clinically suitable for treatment with the HARPOON™ System, as per the Instructions for Use (IFU), will be evaluated for inclusion in the registry.
排除标准
- 未提供
结局指标
主要结局
Freedom From Re-operation Due to Recurrent Severe Mitral Regurgitation Through 1-year Post-implant
时间窗: 1 year post-implant
Subject's freedom from re-operation due to recurrent severe mitral regurgitation through 1-year post-implant
次要结局
未报告次要终点
研究者
研究点 (14)
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