NCT03681834已完成不适用
Multi-center Register for the Use of the Cor-Knot® Automated Knotting System in Heart Valve Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 557
- 试验地点
- 1
- 主要终点
- Presence of periprosthetic leak around the prosthetic rings as determined during physical examination (rated yes/no )
研究概览
简要总结
The Cor-Knot® device is an automated knotting system for valve sutures and prosthetic rings used for more than a year during valve replacements and annuloplasties in cardiac surgery. It reduces the time spent knotting the threads fixing the prosthesis and thus reduces aortic clamping and extracorporeal circulation times. The originality of the project is based on the absence of national multi-rate data collection on the effectiveness and safety of the Cor-Knot® knotting device.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •programmed minimally invasive surgery for:
- •aortic valve replacement
- •mitral valve replacement
- •mitral valve plastic surgery
- •adult patient
排除标准
- •emergency surgery
结局指标
主要结局
Presence of periprosthetic leak around the prosthetic rings as determined during physical examination (rated yes/no )
时间窗: Day 30
次要结局
未报告次要终点
研究者
研究点 (1)
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