CTRI/2018/02/011925招募中2/3 期
Left Atrial Appendage Occlusion Study III
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 4,700
- 试验地点
- 6
- 主要终点
- Stroke or systemic arterial embolism
研究概览
简要总结
The primary objective is to examine the impact of LAA occlusion on the incidence of ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism over the duration of follow-up in patients with atrial fibrillation undergoing cardiac surgery with the use of cardiopulmonary bypass.
The primary clinical hypothesis is that patients who have had their LAA occluded/removed will benefit over those on usual care alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age ≥ 18 years of age 2) Undergoing a clinically indicated cardiac surgical procedure with the use of cardiopulmonary bypass 3) A documented history of atrial fibrillation or atrial flutter 4) CHA2DS2-VASc score ≥ 2 5) Written informed consent.
排除标准
- •Patients undergoing any of the following procedures: a.
- •Off-pump cardiac surgery b.
- •Heart transplant c.
- •Complex congenital heart surgery d.
- •Sole indication for surgery is ventricular assist device insertion e.
- •Previous cardiac surgery requiring opening of the pericardium f.
- •Mechanical valve implantation 2) Patients who have had a previous placement of a percutaneous LAA closure device.
结局指标
主要结局
Stroke or systemic arterial embolism
时间窗: Over the duration of follow-up (five years)
First occurrence of ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism
时间窗: Over the duration of follow-up (five years)
次要结局
- All cause stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism(median follow-up of 4 years)
- Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism or death(Common termination point (median follow-up of 4 years))
- Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism 30 days after surgery(Common termination point (median follow-up of 4 years))
- All cause death(median follow-up of 4 years)
研究者
研究点 (6)
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