Strategies for the Prevention of Perioperative Neurological Complications in Cardiac Valve Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Silent brain infarction (SBI)
研究概览
简要总结
In patients with valvular heart disease and atrial fibrillation (AF) undergoing surgical valve surgery, current guidelines recommend concomitant surgical management of the left atrial appendage (LAA) to prevent postoperative thromboembolic events, particularly neurologic embolic events. However, whether concomitant LAA management benefits patients without AF by reducing postoperative neurologic complications remains controversial.
Given these uncertainties, this study aims to evaluate whether concomitant LAA suture closure during surgical valve surgery is associated with a lower incidence of perioperative silent cerebral infarction.
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
- 否
入选标准
- •Adult patients (≥18 years) without atrial fibrillation who are scheduled to undergo open (direct-vision) surgical heart valve surgery and who are informed about the study and provide written informed consent to participate.
排除标准
- •History of prior cardiac surgery
- •history of cerebral infarction (ischemic stroke)
- •emergency surgery
- •infective endocarditis
- •pregnancy
- •refusal or inability to provide informed consent/declines participation in this study.
研究组 & 干预措施
Valve surgery with concomitant LAA suture closure
Concomitant suture closure of the LAA performed during surgical valve surgery.
干预措施: Left Atrial Appendage (LAA) Suture Closure (Procedure)
Valve surgery alone (no LAA procedure)
Standard surgical valve surgery without concomitant LAA suture closure.
干预措施: Surgical Valve Surgery (Procedure)
结局指标
主要结局
Silent brain infarction (SBI)
时间窗: Approximately postoperative day 5
Occurrence of SBI assessed by postoperative brain magnetic resonance imaging (MRI) performed at approximately postoperative day 5.
次要结局
- Perioperative stroke(Within 30 days after surgery)
- Perioperative all-cause mortality(Within 30 days after surgery)
- Perioperative MACCE(Within 30 days after surgery)
- Silent brain infarction (SBI) at 1 year(Occurrence of SBI assessed by brain MRI at 1 year after surgery.)
- MACCE at 1 year(Within 1 year after surgery)