A Comparision of Anitarrhythmic Drug Therapy and Radiofrequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation

This study has been completed.

First Received on October 4, 2007. Last Updated on October 5, 2007 History of Changes

Sponsor:	Biosense Webster, Inc.
Information provided by:	Biosense Webster, Inc.
ClinicalTrials.gov Identifier:	NCT00540787

Purpose

The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in Paroxysmal Atrial Fibrillation Patients.

Condition	Intervention	Phase
Atrial Fibrillation	Device: RF Ablation, AAD	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	A Randomized Comparison of the Efficacy of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation for the Maintenance of Sinus Rhythm In Patients With Paroxysmal Atrial Fibrillation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Biosense Webster, Inc.:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

18 years of age or older
Paroxysmal AF for at least 6 months with at least 2 symptomatic episodes (patient history) during the previous month
AF (patient history or ECG documented) resistant to at least 1 antiarrhythmic of Class I or III
Documentation of at least one episode of AF on 12 lead ECG or Holter monitor

Exclusion Criteria:

Contraindications to more than 2 antiarrhythmic drugs of different classes, or to oral anticoagulants
History of any previous ablation for AF
Intracardiac thrombus
AF due to reversible cause
Pregnancy
Contraindication to stopping oral anticoagulation (for example as a result of a mechanical cardiac valve)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540787

Locations

France
Hôpital Haut Lèvêque
Pessac, Paris, France

Sponsors and Collaborators

Biosense Webster, Inc.

Investigators

Principal Investigator:

Pierre Jais, MD

Hôpital Haut Lèvêque

More Information

No publications provided by Biosense Webster, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jaïs P, Cauchemez B, Macle L, Daoud E, Khairy P, Subbiah R, Hocini M, Extramiana F, Sacher F, Bordachar P, Klein G, Weerasooriya R, Clémenty J, Haïssaguerre M. Catheter ablation versus antiarrhythmic drugs for atrial fibrillation: the A4 study. Circulation. 2008 Dec 9;118(24):2498-505. Epub 2008 Nov 24.

ClinicalTrials.gov Identifier:	NCT00540787 History of Changes
Other Study ID Numbers:	A4
Study First Received:	October 4, 2007
Last Updated:	October 5, 2007
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012