Paroxysmal Atrial Fibrillation
Conditions
Brief summary
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.
Interventions
DEVICERadiofrequency ablation, antiarrhythmic drugs
Patients receive either treatment.
DRUGAmiodarone, 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.
DEVICEThermoCool Radiofrequency Catheter
Patient is ablated once, repeat ablation if paroxysmal atrial fibrillation reoccurs.
Sponsors
Biosense Webster, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of Atrial Fibrillation | One year | To compare the incidence of recurrence of Atrial Fibrillation in the two groups over a follow-up period of one year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of ablation and drug treatment | One year | 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) |
Countries
France, Switzerland, United States
Outcome results
None listed