NCT05688514已完成不适用
TVMR With the Innovalve System Trial - First In Human Israel
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Absence of implant or delivery related serious adverse events at 30 days
研究概览
简要总结
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
详细描述
The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the Innovalve 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
Innovalve TMVR System
Experimental
MV replacement with Innovalve MR system
干预措施: Innovalve MR system (Device)
结局指标
主要结局
Absence of implant or delivery related serious adverse events at 30 days
时间窗: 30 days
Absence of implant or delivery related serious adverse events
次要结局
- Quality of life improvement (KCCQ-12) Kensas City Cardiomyopathy Questionnaire(30 days, 6, 12 months and annually up to 5 years)
- NYHA functional class(30 days, 6, 12 months and annually up to 5 years)
- Six-minute walk test(30 days, 6, 12 months and annually up to 5 years)
- Technical success(Procedure)
- Procedural success(30 days)
- Reduction in Mitral Regurgitation grade(30 days, 6, 12 months and annually up to 5 years)
研究者
研究点 (2)
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