Catheter Ablation as the First Line Therapy for Typical Atrial Flutter

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2007-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Flutter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Radiofrequency catheter ablation of typical atrial flutter

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No