跳至主要内容
临床试验/NCT03681834
NCT03681834已完成不适用

Multi-center Register for the Use of the Cor-Knot® Automated Knotting System in Heart Valve Surgery

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 557 人开始时间: 2018年7月13日最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (1)

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