Isolated Atrial Fibrillation Ablation in Patients With Isolated Atrial Flutter
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number or patients with a recurrence of any atrial arrhythmia
研究概览
简要总结
Ablation of the cavotricuspid isthmus (CTI) in the right atrium is currently the therapy of choice for the treatment of typical atrial flutter (3,4). It is a curative approach and has a high success rate (5). It has been recognized that patients with typical atrial flutter often complain of atrial fibrillation (1,2). Current clinical and experimental studies confirm the close relationship between atrial flutter (AFL) and atrial fibrillation (AF) and raise a question, if both arrhythmias are different forms of a common electrical phenomenon with atrial fibrillation being the underlying clinical problem (6).
详细描述
Current clinical and experimental studies confirm the close relationship between atrial flutter (AFlut) and atrial fibrillation (Afib). After initiation of Afib this may organize under special intrinsic conditions or due to antiarrhythmic medication to AFlut so Afib may be supposed the underlying arrhythmia. Therefore after successful ablation of AFlut this reentrant circuit is not longer possible and Afib persists. After new occurrence of Afib a long diagnostic and therapeutic marathon begins with AF ablation at the end of all therapeutic efforts. This double burden for the patient and the health system can probably be avoided by directly and effectively treating the underlying arrhythmia AF.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with- in 12-Channel-ECG documented atrial tachycardia suggestive of typical isthmus dependent atrial flutter
- •> 21 years
排除标准
- •- AFL as secondary to an accessory pathway
- •Antiarrhythmic treatment for AF
- •Previous AF ablation
- •Dilatation of left atrium > 6 cm
- •Cardiac surgery less < 3 weeks
- •Congenital heart disease
- •Cardiac ischemia or coronary artery disease that needs intervention
- •Life expectancy less than 2 years
研究组 & 干预措施
Pulmonary vein isolation
pulmonary vein isolation
干预措施: Pulmonary vein isolation (Procedure)
Cavo-tricuspid-isthmus-ablation
Ablation of atrial flutter
干预措施: Cavo-tricuspid-isthmus-ablation (Procedure)
Antiarrhythmic drug
Medical treatment of atrial flutter with either class I antiarrhythmics (flecainide (Tambocor ®) 100 mg twice daily or propafenone (Rytmonorm ®) up to 150 mg 3 times daily) or amiodarone (Cordarex®) 200 mg daily
cardioversion as needed
干预措施: Antiarrhythmic drug (Drug)
结局指标
主要结局
Number or patients with a recurrence of any atrial arrhythmia
时间窗: 2 years
Number (percentage) of patients with any atrial arrhythmia lasting longer than 30 s after ablation assessed by implantable loop recorder or 7-day-holter-ECG: AFL after AF ablation compared to the AFL ablation group and AF in both ablation groups
次要结局
- Number of patients with atrial flutter recurrence(2 years)
研究者
Dietmar Baensch
Professor Dr. med.
University of Rostock