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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: Radiofrequency ablation, antiarrhythmic drugs
* Drug: Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs
* Device: ThermoCool Radiofrequency Catheter


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug Treatment<br> | Device: Radiofrequency ablation, antiarrhythmic drugs<br>* Patients receive either treatment.<br>Drug: Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs<br>* 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.<br>|
| Active Comparator: ThermoCool Radiofrequency Catheter<br>Radiofrequency catheter used. | Device: Radiofrequency ablation, antiarrhythmic drugs<br>* Patients receive either treatment.<br>Device: ThermoCool Radiofrequency Catheter<br>* Patient is ablated once, repeat ablation if paroxysmal atrial fibrillation reoccurs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of Atrial Fibrillation | To compare the incidence of recurrence of Atrial Fibrillation in the two groups over a follow-up period of one year. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of ablation and drug treatment | Evaluation of: the functional state of the 2 groups of patients in terms of quality of life the efficacy of the subgroup receiving amiodarone as compared to curative ablation the incidence of secondary effects of both approaches the rate of withdrawal from oral anticoagulation at 1 year after randomization the effect of ablation for maintenance of sinus rhythm with previously ineffective drugs in case of failure of ablation strategy (after cross-over to medical treatment) the assessment of Atrial fibrillation burden in both groups (using patient diaries and Holter Monitors) | One year |