Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Reduced incidence of Postoperative Atrial fibrillation
研究概览
简要总结
Atrial Fibrillation (AF) is one of the most common postoperative complications after coronary artery bypass grafting (CABG). Postoperative AF produces a substantial impact on hospital resources with an estimated annual expenditure of over $1 billion. This includes the cost of pharmacological treatment and the cost of the increased length of stay. The incidence of AF is about 30-40% in CABG patients and increases with age of the patient. As the average age of the patient that undergoes CABG surgery is increasing, it is critical to find a way to prevent or reduce the incidence of this complication.
We propose a prospective, randomized, controlled study to determine the role of pulmonary vein isolation by bipolar ablation in the prevention or reduction of postoperative AF. The block- randomization plan will be used to maintain balance of the study and control arms throughout the study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who require an isolated elective CABG surgery on CPB.
- •Both male and female patients of age 18 years to 90 years.
排除标准
- •Pre existing atrial fibrillation or history of previous atrial fibrillation.
- •Inability to provide informed consent.
- •Pregnant or nursing patients.
- •Reoperative sternotomy
- •Emergency CABG surgery.
研究组 & 干预措施
Pulmonary Vein isolation
Patients in this arm will receive pulmonary vein isolation during surgery
干预措施: Isolation of pulmonary veins with Bipolar radiofrequency ablation (Procedure)
Standard of care
Subjects in this arm will receive standard of care and no pulmonary vein isolation
结局指标
主要结局
Reduced incidence of Postoperative Atrial fibrillation
时间窗: 12 hours
次要结局
未报告次要终点
研究者
Lawrence Wei
Associate Professor
University of Pittsburgh
