Clinical Trial: Catheter Ablation as the First Line Therapy for Typical Atrial Flutter
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Catheter Ablation as the First Line Therapy for Symptomatic Typical Atrial Flutter: A Multicenter Randomized Study of Cost/Effectiveness
Brief Summary: 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.
Detailed Summary:
Sponsor: University Hospital, Rouen
Current Primary Outcome: Absence of typical atrial flutter recurrence at 6 and 12 months
Original Primary Outcome: Same as current
Current Secondary Outcome: Cost/effectiveness ratio at 12 months
Original Secondary Outcome: Same as current
Information By: University Hospital, Rouen
Dates:
Date Received: September 13, 2005
Date Started: June 2001
Date Completion:
Last Updated: June 17, 2013
Last Verified: June 2013