跳至主要内容
临床试验/NCT04220047
NCT04220047招募中不适用

Fuwai Hospital, Chinese Academy of Medical Science

China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年4月30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
400
试验地点
1
主要终点
postoperative new-onset atrial fibrillation

研究概览

简要总结

Surgical occlusion of the left atrial appendage (LAAO) is sometimes performed during the cardiac surgery to reduce long-term risk of stroke.A previous study found that LAAO may be associated with increased risk of postoperative atrial fibrillation.New-onset atrial fibrillation (NOAF) after coronary artery bypass graft is related to an increased short-term and long term risk of stroke and mortality.Marshall ligament amputation may reduce the occurence of atrial fibrillation. However, little is known whether this approach is justified during the coronary artery bypass graft.Therefore, this study aimed to investigate whether LAAO and Marshall ligament amputation during off-pump coronary artery bypass was associated with reduced risks of postoperative new-onset atrial fibrillation and stroke.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • isolated first off-pump coronary artery bypass

排除标准

  • Preoperative atrial fibrillation or a history of atrial fibrillation;
  • Concurrent cardiac or non-cardiac surgery
  • Intraoperative convert to bypass bypass surgery
  • Emergency surgery
  • History of previous cardiac surgery
  • Severe organ dysfunction

结局指标

主要结局

postoperative new-onset atrial fibrillation

时间窗: 7 days

Postoperative atrial fibrillation (POAF), defined as new-onset atrial fibrillation (AF) in the immediate period after surgery, is the most important type of secondary AF.

次要结局

  • stroke(1 months,3 months, 1years, 3years, 5years.)

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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