Biventricular Pacing After Coronary Artery Bypass Grafting (BIVAC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Duration of Intensive Care Treatment
研究概览
简要总结
The purpose of this study is to determine which pacing mode after coronary artery bypass grafting in patients with reduced left ventricular function is hemodynamically favorable.
详细描述
Patients with severely reduced left ventricular function undergoing coronary artery bypass grafting (CABG) are at an increased perioperative risk and often need prolonged postoperative treatment on intensive care units. A significant portion of these patients require postoperative pacing. Right ventricular pacing has been shown to be hemodynamically deleterious whereas biventricular pacing improves cardiac output in patients with severely reduced left ventricular function and bundle branch block. The purpose of this study is to compare DDD-right ventricular, DDD-biventricular and AAI pacing in CABG patients with an ejection fraction less than 40% in a prospective randomized setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
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
- •Elective or urgent coronary artery bypass grafting
- •Preoperative ejection fraction less than 40%
排除标准
- •Existing permanent pacemaker or ICD
- •Concomitant valve surgery
- •Preoperative cardiovascular instability requiring intubation or IABP use
- •Chronic renal failure requiring dialysis
- •Failure to provide informed consent
结局指标
主要结局
Duration of Intensive Care Treatment
次要结局
- 30 day mortality
- Major adverse events
- Duration of Hospital Stay
- Hemodynamic parameters
- Inotrope use
- Atrial fibrillation
- Ventricular tachycardia / ventricular fibrillation
- Renal function
- Stability of pacing wires