NCT03988946已完成不适用
Cephea Mitral Valve and Transseptal Delivery System FIH
Cephea Valve Technologies1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Safety as measured by freedom from major adverse events
研究概览
简要总结
To assess the safety and performance of the Cephea Transseptal Mitral Valve System for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation, in patients who are poor candidates for surgery.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Safety as measured by freedom from major adverse events
时间窗: 30 days
Freedom from major adverse events, including: * All-cause mortality * Disabling stroke * Myocardial infarction * Renal failure requiring dialysis * Life-threatening bleeding * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention.
Performance
时间窗: 30 days
Reduction in mitral regurgitation to ≤1+
次要结局
未报告次要终点
研究者
研究点 (1)
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