跳至主要内容
临床试验/NCT00213408
NCT00213408终止4 期

Catheter Ablation as the First Line Therapy for Symptomatic Typical Atrial Flutter: A Multicenter Randomized Study of Cost/Effectiveness

University Hospital, Rouen2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2001年6月1日最近更新:
适应症

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

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

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (2)

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