Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 585
- 试验地点
- 24
- 主要终点
- Proportion of subjects free of Major Adverse Events (MAEs) in the treatment group when compared to subjects in the control group.
研究概览
简要总结
The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is a candidate for mitral valve repair with cardiopulmonary bypass
- •Has Grade III moderate or Grade IV severe degenerative mitral valve regurgitation
- •Primary segmental prolapse of the A2 or P2 segment or prolapse extending to an adjacent segment (P1, P3, A1, A3) who have a single eccentric regurgitant jet on echocardiogram
- •Anterior leaflet covers at least 65% of anterior-posterior annular distance or an anterior leaflet that would provide sufficient coaptation after chord placement
- •Anatomic and general suitability
排除标准
- •Prior mitral valve surgery
- •Concomitant cardiac procedures
- •Other cardiac procedures within 3 months
研究组 & 干预措施
Treatment Group
Subjects with degenerative mitral valve insufficiency treated with artificial chordae implanted using the NeoChord DS1000
干预措施: NeoChord DS1000 (Device)
Control Group
Subjects with degenerative mitral valve insufficiency treated with standard surgical mitral valve repair
干预措施: Surgical Mitral Valve Repair (Device)
结局指标
主要结局
Proportion of subjects free of Major Adverse Events (MAEs) in the treatment group when compared to subjects in the control group.
时间窗: Post-operative Day (POD) 30
Proportion of subjects free of Grade II, III or IV mitral regurgitation, mitral valve replacement or mitral valve reintervention in the treatment group when compared to subjects in the control group.
时间窗: 1 year
次要结局
未报告次要终点