Catheter Ablation as the First Line Therapy for Typical Atrial Flutter
Primary Purpose
Atrial Flutter
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Radiofrequency catheter ablation of typical atrial flutter
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Flutter focused on measuring Arrhythmia, atrial flutter, catheter ablation
Eligibility Criteria
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
Sites / Locations
- CHU de Rouen
Outcomes
Primary Outcome Measures
Absence of typical atrial flutter recurrence at 6 and 12 months
Secondary Outcome Measures
Cost/effectiveness ratio at 12 months
Full Information
NCT ID
NCT00213408
First Posted
September 13, 2005
Last Updated
June 17, 2013
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT00213408
Brief Title
Catheter Ablation as the First Line Therapy for Typical Atrial Flutter
Official Title
Catheter Ablation as the First Line Therapy for Symptomatic Typical Atrial Flutter: A Multicenter Randomized Study of Cost/Effectiveness
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
end of the follow-up period
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
Keywords
Arrhythmia, atrial flutter, catheter ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency catheter ablation of typical atrial flutter
Primary Outcome Measure Information:
Title
Absence of typical atrial flutter recurrence at 6 and 12 months
Secondary Outcome Measure Information:
Title
Cost/effectiveness ratio at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
frederic Anselme, MD, PhD
Organizational Affiliation
Service de Cardiologie, Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Rouen
City
Rouen
State/Province
Seine Maritime
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
Learn more about this trial
Catheter Ablation as the First Line Therapy for Typical Atrial Flutter
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