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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
University Hospital, Rouen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Flutter focused on measuring Arrhythmia, atrial flutter, catheter ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 13, 2005
Last Updated
June 17, 2013
Sponsor
University Hospital, Rouen
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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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