Multicenter Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 280
- 试验地点
- 4
- 主要终点
- Incidence of atrial fibrillation after CABG
研究概览
简要总结
To compare prophylactic strategies of atrial fibrillation in patients with CAD and without AF.
详细描述
Prospective, multicenter, randomized trial, intended to compare three prophylactic strategies of atrial fibrillation in patients with coronary artery disease and without history of atrial fibrillation.
The study includes 4 groups of patients:
Group I (conventional CABG)
Group II (CABG + pulmonary veins isolation). Concomitant CABG and epicardial bipolar radiofrequency pulmonary veins isolation.
Group III (CABG+ pulmonary veins isolation + amiodarone). Concomitant CABG and epicardial bipolar radiofrequency pulmonary veins ablation with administration of amiodarone in postoperative periode.
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
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients must have signed an informed consent.
- •patients had indications for two or more coronary arteries to be bypassed
- •no history of AF
排除标准
- •acute coronary syndrome
- •previous CABG.
- •a significant decrease in the contractile function of the heart (EF <40%)
- •significant heart valve disease requiring surgical repair
- •long-standing persistent, persistent, or paroxysmal forms of atrial fibrillation
- •respiratory failure
- •left ventricular aneurysm requiring surgical correction
- •chronic renal failure (≤60 mL/min/1⋅73 m2)
- •chronic diseases that make a significant contribution to the prognosis of life (e.g. oncology)
- •participation in other clinical trials
结局指标
主要结局
Incidence of atrial fibrillation after CABG
时间窗: Through study completion, an average of 1 year
Major cardiovascular and cerebral events (MACCE), including death, nonfatal myocardial infarction, repeated revascularization using PCI or CABG, transitory ischemic attack (TIA) or stroke.
时间窗: Through study completion, an average of 1 year
次要结局
- Time of CBP(Through study completion, an average of 1 year)
- Duration of the hospitalization(Through study completion, an average of 1 year)
- Time clamping of the aorta(Through study completion, an average of 1 year)
- Sinus rhythm at the time of discharge of the patient from the hospital(Through study completion, an average of 1 year)
- Duration of mechanical ventilation(Through study completion, an average of 1 year)
- Incidence of implantation of the pacemaker(Through study completion, an average of 1 year)
- Volume of intraoperative bleeding(Through study completion, an average of 1 year)
- Length of stay in the intensive care unit(Through study completion, an average of 1 year)
研究者
Stepanova Yulia Aleksandrovna
Clinical Professor
National Research Center of Surgery, Russia