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

Biosense Webster

Status and phase: Completed; Phase 4

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: ThermoCool Radiofrequency Catheter; Drug: Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs; Device: Radiofrequency ablation, antiarrhythmic drugs

Study type: Interventional

Funder types: Industry

Identifiers

NCT00540787

A4

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Drug Treatment

Active Comparator group

Treatment:

Device: Radiofrequency ablation, antiarrhythmic drugs

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

ThermoCool Radiofrequency Catheter

Active Comparator group

Description:

Radiofrequency catheter used.

Treatment:

Device: Radiofrequency ablation, antiarrhythmic drugs

Device: ThermoCool Radiofrequency Catheter