Cephea Early Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 38
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart 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
- •Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm² and/or mean transmitral gradient ≥10 mmHg at normal heart rate) per American Society of Echocardiography criteria.
- •LVEF ≥ 30%
- •In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.
排除标准
- •Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
- •Need for emergent or urgent surgery.
研究组 & 干预措施
Treatment
Treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System
干预措施: Cephea Mitral Valve System (Device)
结局指标
主要结局
Primary Safety Endpoint
时间窗: 30 days post implant
Freedom from all-cause mortality, which will be assessed at 30 days post implant.
Primary Effectiveness Endpoint
时间窗: 30 days post implant
Proportion of subjects with reduction of MR to ≤ Grade I, will be assessed at 30 days post implant.
次要结局
未报告次要终点