跳至主要内容
临床试验/NCT00665587
NCT00665587Unknown不适用

Surgical Treatment of Atrial Fibrillation - Prospective Randomized Study

Charles University, Czech Republic3 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2007年6月最近更新:
适应症

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

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)

研究者

发起方
Charles University, Czech Republic
申办方类型
Other

研究点 (3)

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