NCT00567853已完成3 期
Clinical Investigation Of The Sorin 3D Annuloplasty Ring For Mitral Repair
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 12
- 主要终点
- The percentage of patients with successful repair at 6 months.
研究概览
简要总结
The purpose of this study is to collect data on the effectiveness and clinical outcomes of the MEMO 3D Annuloplasty ring as used for mitral valve repair.
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
- •The subject is 18 years old or older
- •An annuloplasty ring is indicated for reinforcement of a dysfunctional or diseased native mitral valve according to the current medical practice for valvular repair at each site.
- •The subject is able to return for all follow-up evaluations of the study.
排除标准
- •The subject or subject's legal representative is unwilling to sign the informed consent.
- •The subject is or will be participating in another medical device or drug clinical trial.
- •The subject is a minor, prisoner, institutionalized, or is unable to give informed consent.
- •The subject has a life expectance of less than 1 year.
结局指标
主要结局
The percentage of patients with successful repair at 6 months.
时间窗: One Year
次要结局
- Freedom from re-operation at 12 months. Preoperative and postoperative mitral valve regurgitation and LV dimensions and mass assessed by echocardiography. Actuarial survival and freedom from clinical events at 12 months.(12 months)
研究者
研究点 (12)
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