Thermocool Navigation Catheters: Phase III data

The open-label, international Phase III RAFFT trial in 127 patients showed that first-line pulmonary vein isolation performed by radiofrequency catheter ablation met the primary endpoint of extending time to first recurrence of symptomatic or asymptomatic AF, atrial tachyarrhythmia and atrial flutter vs. anti-arrhythmic drugs. Specifically, at a mean follow-up of 756 days, 54.5% of patients receiving catheter ablation had an AF recurrence vs. 72.1% of patients receiving anti-arrhythmic drugs (HR=0.56, p=0.016). The incidence of treatment-related adverse events was 7.7% in patients receiving catheter ablation vs. 19.5% in patients receiving anti-arrhythmic drugs. No deaths were reported in either arm. The trial enrolled patients with paroxysmal recurrent AF who had not previously received an anti-arrhythmic drug to receive catheter-based pulmonary vein isolation or anti-arrhythmic drug therapy consisting of Multaq dronedarone from Sanofi (Euronext:SAN; NYSE:SNY, Paris, France) or the generics flecainide, propafenone, sotalol and amiodarone. ...