NCT04820764招募中不适用
Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)
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
- 25
- 试验地点
- 24
- 主要终点
- Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure
研究概览
简要总结
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
详细描述
The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe (≥3+) or severe (≥4+), symptomatic, degenerative mitral regurgitation and who are determined to be at intermediate or high surgical risk for mitral valve repair, as assessed by the site's multidisciplinary heart team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Eighteen (18) years of age or greater
- •Moderate to severe (≥3+) or severe (≥4+) mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail
- •Intermediate or high surgical risk for mitral valve repair
排除标准
- •History of rheumatic heart disease
- •History of prior endocarditis
- •History of prior repair or replacement of the mitral valve, or annuloplasty
- •Severely calcified mitral leaflet or has evidence of calcification in the grasping area of the leaflets that would prevent leaflet anchor positioning and deployment
- •Complex mechanism of MR (leaflet perforation, severe leaflet calcifications, commissural extension, commissural prolapse, multiple flail or prolapsing segments, cleft) present on required imaging
研究组 & 干预措施
CardioMech Mitral Valve Repair System (MVRS)
Experimental
干预措施: CardioMech MVRS (Device)
结局指标
主要结局
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure
时间窗: 30 days
Change in MR grade
时间窗: 30 days
次要结局
未报告次要终点
研究者
研究点 (24)
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