NCT02718001
进行中（未招募）
不适用
Edwards EVOQUE Eos Mitral Valve Replacement: Investigation of Safety and Performance After Mitral Valve Replacement With Transcatheter Device (MISCEND)
Edwards Lifesciences29 个研究点 分布在 2 个国家目标入组 123 人2015年2月6日
概览
- 阶段
- 不适用
- 干预措施
- Edwards EVOQUE Eos Mitral Valve Replacement System
- 疾病 / 适应症
- Mitral Valve Regurgitation (Degenerative or Functional)
- 发起方
- Edwards Lifesciences
- 入组人数
- 123
- 试验地点
- 29
- 主要终点
- Composite of major adverse events
- 状态
- 进行中（未招募）
- 最后更新
- 19天前
概览
简要总结
Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system
详细描述
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system.
研究者
入排标准
入选标准
- •Clinically significant, symptomatic mitral regurgitation
- •High risk for open-heart surgery
- •Meets anatomical criteria
排除标准
- •Unsuitable anatomy
- •Patient is inoperable
研究组 & 干预措施
Treatment
Treatment with the Edwards EVOQUE Eos mitral valve replacement system
干预措施: Edwards EVOQUE Eos Mitral Valve Replacement System
结局指标
主要结局
Composite of major adverse events
时间窗: 30 days
Proportion of patients with major adverse events
次要结局
- NYHA functional class(30 days, 6 Months, 12 Months, annual for five years)
- Clinical Success(30 days)
- Procedural Success(Discharge or 7 days post-procedure, whichever occurs first)
- Reduction in MR grade(30 days, 6 Months, 12 Months, annual for five years)
- Device Success(Immediately after procedure)
- Six minute walk test(30 days, 6 Months, 12 Months, annual for five years)
研究点 (29)
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