A comparison of epicardial and endocardial suture occlusion surgical techniques for left atrial appendage occlusion in patients undergoing mitral valve surgery: A pilot prospective randomized comparative study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- to study efficacy of two surgical techniques in complete occlusion of left atrial appendage: epicardial and endocardial occlusion suture occlusion in patients undergoing mitral valve surgery
研究概览
简要总结
this randomized control trial (pilot study) aims to compare effectiveness of two surgical techniques for left atrial appendage (LAA) occlusion during mitral valve surgery in preventing thromboembolic events and improving clinical outcomes. post-operative atrial fibrillation (POAF) occurs in 20-25% of cardiac surgeries, increasing risk of stroke and mortality. The LAA is responsible for 90% of left atrial thrombi in atrial fibrillation patients, is commonly managed through surgical occlusion or excision. Despite guidelines recommending LAA closure/ occlusion no consensus exists on best technique. This prospective, single blinded RCT will evaluate short term clinical outcomes and long-term thromboembolic risk to identify the optimal LAA management strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator 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
- •All patients undergoing mitral valve surgery with or without tricuspid valve surgery above the age of 18 years to 80 years are included.
排除标准
- •Redo Surgery including closed mitral valvotomy Recent onset cardio-embolic stroke Less than six weeks Patients requiring concomitant surgical intervention for critical coronary, carotid artery disease.
- •â€¢ Coagulopathy • Emergency Surgery • Refusal to participate in the study.
结局指标
主要结局
to study efficacy of two surgical techniques in complete occlusion of left atrial appendage: epicardial and endocardial occlusion suture occlusion in patients undergoing mitral valve surgery
时间窗: to study efficacy of two surgical techniques in complete occlusion of left atrial appendage: epicardial and endocardial occlusion suture occlusion in patients undergoing mitral valve surgery
次要结局
- to compare incidence of cardioembolic stroke in patients of both groups(to compare outcomes in incidence of postoperative complications: reoperation for bleeding, acute renal failure, respiratory failure, cerebrovascular accidents, mortality)
研究者
Deepak Sharma
All India Institute of Medical Sciences, Rishikesh