NCT05682066已完成不适用
TVMR With the Innovalve System Trial - Pilot in Georgia
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
- 11
- 试验地点
- 1
- 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 pilot 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
- Reduction in Mitral Regurgitation grade(30 days, 6, 1 year)
- Six-minute walk test(30 days, 6, 1 year)
- Quality of life improvement (KCCQ-12) Kansas City Cardiomyopathy Questionnaire(30 days, 6, 1 year)
- Technical success(Procedure)
- Procedural success(30 days)
- NYHA functional class(30 days, 6, 1 year)
研究者
研究点 (1)
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