NCT01784055已完成不适用
Post-Market Surveillance Registry for the NeoChord DS1000
NeoChord7 个研究点 分布在 5 个国家目标入组 126 人开始时间: 2013年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 7
- 主要终点
- Procedure Success
研究概览
简要总结
To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade 3+ or 4+ mitral valve regurgitation
排除标准
- •Heavily calcified valves
- •Valvular retraction with severely reduced mobility
- •Active bacterial endocarditis
- •Complex mechanism of MR (leaflet perforation, etc.)
- •Significant tethering of leaflets
- •Inflammatory valve disease
结局指标
主要结局
Procedure Success
时间窗: The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day.
To describe the rate of subjects with at least one neochord placed using the DS1000 System AND a reduction in mitral regurgitation ≤ 2+ at the time of the procedure
次要结局
未报告次要终点
研究者
研究点 (7)
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