FLAT Study: First Line Ablation Therapy for Treatment of Paroxysmal Atrial Fibrillation (RAAFT)

The objective of this multicenter randomized study is to establish the effectiveness of treatment for paroxysmal atrial fibrillation (AF), in patients not previously treated with anti-arrhythmic drugs, by encircling the pulmonary veins with radiofrequency (RF) ablation, using the NaviStar® ThermoCool® catheter and the CARTO™ EP Navigation System. Effectiveness will be determined by comparing chronic success of ablation therapy versus anti-arrhythmic drug treatment, defined as patients with an absence of atrial tachycardias during 24 months of follow-up as determined by 7-days Holter and transtelephonic monitoring, and by 12-lead electrocardiogram (ECG) recordings.

Inclusion Criteria: * Informed consent obtained * Two or more documented symptomatic paroxysmal atrial fibrillation episodes during the last 6 months. Episodes should last longer than 30 seconds. * Patients should not be on anti-arrhythmic medication therapy (Class I, III or IV) for AF (other than for cardioversion) or are currently on antiarrhythmic drug (AAD) therapy for any other arrhythmia Exclusion Criteria: * Patients who had a previous ablation for atrial fibrillation * Patients who had presence of severe valvular disease, myocardial infarction and/ or cardiomyopathy * Patients with a left atrial size more than 50 mm * Patients who had more than 2 cardioversions * Patients who have a history of AF for less than 3 months or more than one year * Patients with solely asymptomatic AF * Patients who have AF episodes triggered by another uniform arrhythmia * Patients who actively abuse alcohol or other drugs, which may be causative of AF * Patients with a tumor, or another abnormality which precludes catheter introduction * Patients with a revascularization or other cardiac surgery within 6 months before study treatment * Patients in whom appropriate vascular access is precluded * Patients with a contraindication to treatment with warfarin or other bleeding diathesis participants in another investigational clinical or device trial * Patients who are inaccessible for follow-up psychological problem that might limit compliance * Patients who cannot or will not fulfill the follow-up or protocol requirements * Pregnant women * Patients with severe chronic obstructive pulmonary disease * Patients with Wolff-Parkinson-White (WPW) syndrome * Patients with renal failure requiring dialysis * Patients with hepatic failure