Catheter Ablation as the First Line Therapy for Typical Atrial Flutter

Atrial Flutter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00213408
• Other study ID #: 1999/026/HP
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: June 17, 2013
• Start date: June 2001
• Est. completion date: January 2007

Study information

• Verified date: June 2013
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• first episode of symptomatic typical atrial flutter

• > 18 years old

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

Procedure:
• Radiofrequency catheter ablation of typical atrial flutter

Locations

Country	Name	City	State
France	CHU de Rouen	Rouen	Seine Maritime

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of typical atrial flutter recurrence at 6 and 12 months
Secondary	Cost/effectiveness ratio at 12 months