Catheter Ablation as the First Line Therapy for Typical Atrial Flutter
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ClinicalTrials.gov Identifier: NCT00213408
Recruitment Status :
(end of the follow-up period)
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.
Condition or disease
Procedure: Radiofrequency catheter ablation of typical atrial flutter
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
first episode of symptomatic typical atrial flutter
> 18 years old
Prior antiarrhythmic drug treatment for atrial flutter
History of cavotricuspid isthmus ablation
contraindication for anticoagulant therapy
Life expectancy < 1 year
contraindication to catheter ablation or to electrical cardioversion