Catheter Ablation as the First Line Therapy for Typical Atrial Flutter
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Atrial Flutter |
Procedure: Radiofrequency catheter ablation of typical atrial flutter |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Catheter Ablation as the First Line Therapy for Symptomatic Typical Atrial Flutter: A Multicenter Randomized Study of Cost/Effectiveness |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| CHU de Rouen | |
| Rouen, Seine Maritime, France, 76031 | |
| Principal Investigator: | frederic Anselme, MD, PhD | Service de Cardiologie, Rouen University Hospital |
More Information
No publications provided
| Responsible Party: | University Hospital, Rouen |
| ClinicalTrials.gov Identifier: | NCT00213408 History of Changes |
| Other Study ID Numbers: | 1999/026/HP |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 17, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Rouen:
|
Arrhythmia atrial flutter catheter ablation |
Additional relevant MeSH terms:
|
Atrial Flutter Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013