Left Atrial Appendage Closure by Surgery-2
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,500
- 试验地点
- 4
- 主要终点
- Number of participants with Stroke occurrence including Transitory cerebral ischemia (TCI)
研究概览
简要总结
Atrial fibrillation is a heart rhythm disorder that often occurs after heart surgery. During atrial fibrillation blood cloths may form, predominantly in the left atrial appendage, a small sac in the wall of the left side of the heart. Some heart surgeons close this appendage to protect against stroke, particularly in patients with a history of atrial fibrillation, yet there is little evidence to support the efficacy and safety of this practice.
We therefore conducted the Left Atrial Appendage Closure by Surgery (LAACS) study (2010-2016) were patients in whom the appendage was closed (by chance) suffered fewer brain damages that patients where it remained open. Although encouraging, these results were not only based on strokes, but also on scars without symptoms found in brain scans. The following LAACS-2 study will include a sufficient number of patients to determine whether future guidelines should advise to close systematically the left atrium appendage during a heart operation.
详细描述
Aim:
The overall aim of the project is to provide lifelong protection against brain damage related to atrial fibrillation, to patients who undergo open heart surgery.
Background:
Formation of thrombi in the left atrium appendage (LAA) during atrial Fibrillation (AF) can provoke strokes, (shortened - references 1-14) The investigators hypothesis is that systematic closure of the LAA, in addition to planned open-heart surgery, can reduce cerebral embolisms derived from thrombus formation in the left atrium. The investigators performed the LAACS study (clinicaltrial.gov NCT02378116) to test this hypothesis, which is the first randomized study that shows a protective effect of closure of the LAA during surgery, against ischemic damage of the brain, a question that has eagerly been sought in the scientific community. 1-3 The results of the LAACS trial demonstrate a benefit including clinical significant stroke and silent infarctions, 15 with 5 (5%) primary events in the LAACS-group and 14 (16%) in the control group (Hazard ratio 0.3; 95% CI: 0.1-0.8, p=0.02). Nevertheless, a limited number of patients were randomized in LAACS (N 187) of whom 141 followed the procedure. Expectedly, differences on stroke were not significant. Hence, although encouraging, results should be proven in a larger trial, before a systematic closure of the LAA can be recommended as a routine procedure during open-heart surgery. The main purpose of LAACS2 is to provide evidence to support or not such procedure.
Methods:
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
- Single (Outcomes Assessor)
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
- •Patients referred for planned first-time heart surgery:
- •Coronary artery by-pass surgery (CABG)
- •Valve surgery
- •Combined CABG and valve surgery
排除标准
- •Endocarditis
- •No possible follow-up
- •Planned closure of the left atrium appendage as part of surgery
结局指标
主要结局
Number of participants with Stroke occurrence including Transitory cerebral ischemia (TCI)
时间窗: at least two years, until end of follow-up
Stroke is an acute episode of focal dysfunction of the brain, retina, or spinal cord lasting longer than 24 h, or of any duration if imaging (CT or MRI) or autopsy show focal infarction relevant to the symptoms. Transitory cerebral ischemia (TCI) is defined as above, but with symptoms lasting less than 24 h. Endpoints will be assigned by two independent neurologists, who are blinded to what procedure the patient undergo. In case of discrepancy, the events will be assigned by consensus.
次要结局
- Ischemic Stroke, including TCI(at least two years, until end of follow-up)
- Combined end-point of Stroke, TCI or Silent brain infarction(at least two years, until end of follow-up)
- Composite outcome of all-cause mortality and stroke (ischemic or hemorrhagic)(at least two years, until end of follow-up)
研究者
Helena DOMINGUEZ
MD, PhD, Associate Professor
University Hospital Bispebjerg and Frederiksberg