ClinicalTrials.Veeva

Menu

Catheter Ablation as the First Line Therapy for Typical Atrial Flutter

U

University Hospital, Rouen

Status and phase

Terminated
Phase 4

Conditions

Atrial Flutter

Treatments

Procedure: Radiofrequency catheter ablation of typical atrial flutter

Study type

Interventional

Funder types

Other

Identifiers

NCT00213408
1999/026/HP

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems