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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014