Trial | NCT00540787  Report issue

Title

A Comparison of Antiarrhythmic Drug Therapy and Radio Frequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation
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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    112
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.
Study Started
Aug 31
2003
Primary Completion
Jun 30
2006
Study Completion
Jun 30
2006
Last Update
Feb 22
2012
Estimate

Device Radiofrequency ablation, antiarrhythmic drugs

Patients receive either treatment.

Drug Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs

Amiodarone will be taken at 600 mg per day for 21 days (as a loading dose) followed by 1.4g per week or 200mg per day. The daily dose may be increased to 300mg or 2.1g per week.

Device ThermoCool Radiofrequency Catheter

Patient is ablated once, repeat ablation if paroxysmal atrial fibrillation reoccurs.

Drug Treatment Active Comparator

ThermoCool Radiofrequency Catheter Active Comparator

Radiofrequency catheter used.

Criteria 

Inclusion Criteria:

18 years of age or older
Paroxysmal atrial fibrillation for at least 6 months with at least 2 symptomatic episodes (patient history) during the previous month
Atrial fibrillation (patient history or echocardiogram documented) resistant to at least one antiarrhythmic drug of Class I or III
Documentation of at least one episode of atrial fibrillation on 12-lead echocardiogram 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 atrial fibrillation
Intracardiac thrombus
Atrial fibrillation due to reversible cause
Pregnancy
Contraindication to stopping oral anticoagulation (for example as a result of a mechanical cardiac valve)
No Results Posted