Conditions: Atrial Fibrillation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 129
Healthy volunteers: no

Brief summary:
The objective of this prospective multicenter randomized study is to establish the effectiveness of treatment of persistent atrial fibrillation by encircling the pulmonary veins with radiofrequency (RF) ablation and creating additional lines of block with the aid of the NAVISTAR® THERMOCOOL® catheter in conjunction with the CARTO™ EP Navigation System. Effectiveness will be determined by comparing the chronic success of ablation therapy versus antiarrhythmic drug therapy, defined as the absence of persistent tachyarrhythmias during the first 24 months after a run-in phase of 2 months.

Detailed description:

Arms:
arm 1: Catheter ablation arm 2: Antiarrhythmic drugs

Interventions: intervention 1: RF ablation intervention 2: Antiarrhythmic drugs
Intervention descriptions: intervention 1: Catheter ablation with NAVISTAR® THERMOCOOL® Catheter in conjunction with CARTO™ EP Navigation System intervention 2: Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study

Protocol document: