NCT01777815已完成不适用
Safety and Performance Study of the NeoChord Suturing Device in Subjects With Degenerative Mitral Valve Disease; Diagnosed With Severe Mitral Regurgitation
NeoChord9 个研究点 分布在 4 个国家目标入组 30 人开始时间: 2009年10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
- 30
- 试验地点
- 9
- 主要终点
- Procedural Success
研究概览
简要总结
The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in patients with mitral regurgitation.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 and < 80 years
- •Candidate for surgical mitral valve repair or replacement
- •Isolated posterior leaflet prolapse
- •Moderate to severe or severe mitral valve regurgitation that is degenerative in nature
排除标准
- •Anterior or bi-leaflet prolapse
- •Functional or ischemic MR
- •NYHA Class IV
- •Complex mechanism of MR (leaflet perforation, etc)
- •Significant tethering of leaflets toward LV apex
- •Severely calcified mitral valve annulus
- •Inflammatory valve disease
- •Severe LV dilation
结局指标
主要结局
Procedural Success
时间窗: 30 days
The placement of at least one neochord using the DS1000 System AND a reduction in mitral regurgitation \<= 2+ at the time of the procedure AND maintained MR reduction of \<= 2+ at 30 days
次要结局
- Procedural Safety(30 days)
研究者
研究点 (9)
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