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 人开始时间: 2015年2月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 123
- 试验地点
- 29
- 主要终点
- Composite of major adverse events
研究概览
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
- •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
Experimental
Treatment with the Edwards EVOQUE Eos mitral valve replacement system
干预措施: Edwards EVOQUE Eos Mitral Valve Replacement System (Device)
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)
研究者
研究点 (29)
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