NCT04108169Unknown不适用
A Chinese Registry to Evaluate the Association of Surgical Left Atrial Appendage Occlusion vs No Receipt of S-LAAO With Adverse Cardiovascular Events Among Petients Undergoing Coronary Artery Bypass Grafting.
Beijing Institute of Heart, Lung and Blood Vessel Diseases2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2019年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- All-cause death
研究概览
简要总结
This is a prospective, single-center, randomized, active controlled, clinical trail to assess the efficacy and safety of surgical closure of left atrial appendage (LAA) in patients undergoing coronary artery bypass graft.
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 (Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Subject undergoing coronary artery bypass grafting according to clinical indications;
- •Age is more than 18 and less than 80 years old;
- •Male and non pregnancy female;
- •Subject understands study requirements and agrees to sign an informed consent from prior to study procedures.
排除标准
- •Pregnancy female;
- •Participate in other clinical trial in the last 1 month.
- •Subject doesn't agree to sign an informed consent from prior to study procedures.
- •Subject undergoing repeat CABG, concomitant valve or other cardiac surgery.
- •New York Heart Association (NYHA) Class IV heart failure.
结局指标
主要结局
All-cause death
时间窗: 3 year after discharge (These data is collected during follow-up visit at in-hospital)
次要结局
- Atrial fibrillation(3 year after discharge (These data is collected during follow-up visit at in-hospital))
- Composite of ischemic stroke, thromboembolism and all death(3 year after discharge (These data is collected during follow-up visit at in-hospital))
研究者
研究点 (2)
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