Catheter Ablation as the First Line Therapy for Symptomatic Typical Atrial Flutter: A Multicenter Randomized Study of Cost/Effectiveness
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Absence of typical atrial flutter recurrence at 6 and 12 months
研究概览
简要总结
Catheter ablation of typical atrial flutter is a well established technique with a high acute success rate and very low complication and recurrence rates. It has also been shown that ablation of recurrent symptomatic typical atrial flutter led to a clear improvement in quality of life. We sought to evaluate the cost/effectiveness of catheter ablation as the first line therapy in patient suffering from their first symptomatic typical atrial flutter episode. This study is a multicenter trial in which patients with a first symptomatic episode of typical atrial flutter are randomized to undergo ablation or to receive antiarrhythmic drugs after electrical cardioversion. Clinical examination, quality of life questionnaires,12 leads ECG and 24-hour Holter monitoring are performed at 1, 3, 6 and 12 months following randomization.The primary end-point is the absence of recurrence of typical atrial flutter at - and 12 months of follow up. The secondary end points are the cost and the cost/effectiveness ratio of these two approaches.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first episode of symptomatic typical atrial flutter
- •> 18 years old
排除标准
- •Prior antiarrhythmic drug treatment for atrial flutter
- •History of cavotricuspid isthmus ablation
- •Pregnancy
- •Hyperthyroidism
- •contraindication for anticoagulant therapy
- •Life expectancy < 1 year
- •contraindication to catheter ablation or to electrical cardioversion
结局指标
主要结局
Absence of typical atrial flutter recurrence at 6 and 12 months
次要结局
- Cost/effectiveness ratio at 12 months
