NCT05010746进行中（未招募）不适用
TVMR With the Innovalve System Trial - Pilot Study in Italy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 4
- 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
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
MV replacement with Innovalve MR system
Experimental
MV replacement with Innovalve MR system
干预措施: Innovalve TMVR 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 at 30 days
次要结局
- Technical Success(Procedure)
- Procedural Success(30 days)
- Device Success(30 days, 3, 6, 12 months and annually up to 5 years)
- Patient Success(1 year)
- Change in NYHA Class(30 days, 3, 6, 12 months and annually up to 5 years)
- Increase in 6MWD(from baseline to 30 days, 3, 6, 12 months and annually up to 5 years)
- Quality of life change (KCCQ-12)(from baseline to 30 days, 3, 6, 12 months and annually up to 5 years)
- Reduction in MR grade(from baseline to 30 days, 3, 6, 12 months and annually up to 5 years)
- Atrial septal defects requiring closure(30 days, 3, 6, 12 months and annually up to 5 years)
- Change in Montreal Cognitive Assessment (MoCa)(Discharge and 30 days)
- Composite of MVARC criteria(30 days, 3, 6, 12 months and annually up to 5 years)
研究者
研究点 (1)
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