NCT05263375撤回不适用
TVMR With the Innovalve System Trial - Pilot Study in Belgium
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of patients with 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
结局指标
主要结局
Number of patients with implant or delivery related serious adverse events at 30 days
时间窗: 30 days
Number of patients with implant or delivery related serious adverse events at 30 days
次要结局
未报告次要终点
研究者
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