NCT04919980招募中不适用
TVMR With the INNOVALVE System Trial - Early Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 30
- 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 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 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
MV replacement with INNOVALVE system
干预措施: INNOVALVE 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
- Technical success(Procedure)
- Procedural success(30 days)
- Technical success(Procedure)
- Procedural success(30 days)
- Quality of life improvement (KCCQ-12)(30 days, 6, 12 months and annually up to 5 years)
- Reduction in MR grade(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)
研究者
研究点 (30)
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