NCT00213408

Catheter Ablation as the First Line Therapy for Typical Atrial Flutter

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (planned)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Flutter

Interventions

Type	Name	Description
PROCEDURE	Radiofrequency catheter ablation of typical atrial flutter

Timeline

• Start date: 2001-06-01
• Completion: 2007-01-01
• First posted: 2005-09-21
• Last updated: 2013-06-18

Locations

1 site across 1 country: France