FLAT Study: First Line Ablation Therapy for Treatment of Paroxysmal Atrial Fibrillation (RAAFT)
Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
Participant gender:
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.