NCT04190602招募中不适用
The AcChord Study: A Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
NeoChord5 个研究点 分布在 3 个国家目标入组 500 人开始时间: 2020年2月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- Level of Mitral Regurgitation Following the Index Procedure
研究概览
简要总结
The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.
详细描述
This study is an observational, single-arm, multicenter post-market registry. Both prospective and retrospective enrollment will be allowed. No additional invasive or burdensome examinations outside those routinely required for the standard mitral valve repair procedure will be requested.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation
- •Study procedure completed after 31 December 2016
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
Level of Mitral Regurgitation Following the Index Procedure
时间窗: Completion of Index Procedure
Level of mitral regurgitation per echocardiography
次要结局
- Level of Mitral Regurgitation at 5 Years(5 Years)
- Level of Mitral Regurgitation at 3-6 Months(3-6 Months)
- Level of Mitral Regurgitation at 1 Year(1 Year)
- Level of Mitral Regurgitation at 2 Years(2 Years)
- Level of Mitral Regurgitation at 3 Years(3 Years)
- Level of Mitral Regurgitation at 4 Years(4 Years)
研究者
研究点 (5)
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