Catheter Ablation as the First Line Therapy for Typical Atrial Flutter

This study has been terminated.
(end of the follow-up period)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213408
First received: September 13, 2005
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Atrial Flutter
Procedure: Radiofrequency catheter ablation of typical atrial flutter
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Catheter Ablation as the First Line Therapy for Symptomatic Typical Atrial Flutter: A Multicenter Randomized Study of Cost/Effectiveness

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Absence of typical atrial flutter recurrence at 6 and 12 months

Secondary Outcome Measures:
  • Cost/effectiveness ratio at 12 months

Estimated Enrollment: 120
Study Start Date: June 2001
Study Completion Date: January 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213408

Locations
France
CHU de Rouen
Rouen, Seine Maritime, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: frederic Anselme, MD, PhD Service de Cardiologie, Rouen University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213408     History of Changes
Other Study ID Numbers: 1999/026/HP
Study First Received: September 13, 2005
Last Updated: June 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
Arrhythmia
atrial flutter
catheter ablation

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014