Surgical Treatment of Atrial Fibrillation - Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 220
- 试验地点
- 3
- 主要终点
- presence of sinus rhythm
研究概览
简要总结
Aim of the project is to assess the long-time clinical impact of surgical ablation (MAZE procedure) on patients who suffer from atrial fibrillation but are indicated to a cardiac surgery for other predominant cardiac diagnosis (heart valve surgery, coronary revascularization or combined surgery). In recent years, those patients are more and more frequently indicated to some type of MAZE procedure, without the real benefit of this procedure for patients has been assessed with an enough large, randomized study. Even though it is well known, that MAZE procedures declines the early postoperative incidence of atrial fibrillation, convincing data about its mid-term and long-term impact on patients and about the appearance of recidives of atrial fibrillation in long-time horizon are still missing. Our hypothesis assumes, that MAZE procedure will significantly decrease the appearance of atrial fibrillation one year after the operation, without increasing mortality or incidence of serious postoperative complications in thirty postoperative days.
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
- •indication to a cardiac surgery (coronary bypass, valve repair, others or combination of those)
- •atrial fibrillation (paroxysmal, persistent or permanent) present or documented in last 6 month before the operation
- •signed informed consent
排除标准
- •rejection of signing the informed consent with randomization
- •emergent surgery
结局指标
主要结局
presence of sinus rhythm
时间窗: 1 year after surgery
death, myocardial infarction, vascular cerebral attack, renal failure with a need of haemodyalisis
时间窗: 30 postoperative days
次要结局
- mortality, presence of sinus rhythm, serious complications- bleeding, vascular cerebral attack, heart failure, anticoagulation, anti-arrhytmics, pacemaker or ICD implantation, catether ablation...(1,3,5 months 1,5 years after surgery)
