flat study: first line ablation therapy for treatment of paroxysmal atrial fibrillation (raaft)

Conditions: Atrial Fibrillation

Summary: 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.

this study is a prospective, randomized, multicenter clinical study that will enroll in its first phase 40 patients. the study will be performed in 3 european hospitals. patients will be randomized to either the rf ablation strategy or to the medication arm. hypothesis: as first line therapy, catheter ablation improves the long-term success, health-economic outcomes and is equally safe compared to the best anti-arrhythmic medication treatment in a selected group of patients with paroxysmal atrial fibrillation. primary endpoint: * long-term success, defined as patients free from any atrial fibrillation during 24 months after initial study treatment as determined by 7-days holter and transtelephonic monitoring and by 12-lead ecg recordings. secondary endpoints: * af burden: frequency and duration of episodes * health-economic costs over 24 months * serious adverse events * quality of life scores, using sf-36 questionnaire

Eligibility criteria:
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

Keywords: first line ablation therapy