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Catheter Ablation as the First Line Therapy for Typical Atrial Flutter

NCT00213408 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-06-18

No results posted yet for this study

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.

Conditions

  • Atrial Flutter

Interventions

PROCEDURE

Radiofrequency catheter ablation of typical atrial flutter

Sponsors & Collaborators

  • University Hospital, Rouen

    lead OTHER

Principal Investigators

  • frederic Anselme, MD, PhD · Service de Cardiologie, Rouen University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-06-30
Completion
2007-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00213408 on ClinicalTrials.gov