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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
129
Catheter ablation with NAVISTAR® THERMOCOOL® Catheter in conjunction with CARTO™ EP Navigation System
Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months).
Persistent atrial tachyarrhythmia is defined as lasting 7 or more days per two consecutive transtelephonic monitoring or electrocardiogram recordings (obtained at least one week apart) with no cardioversions.
Time frame: within first 24 months after a 2-month run-in phase
Percentage of Participants With Total Absence of Any Documented Atrial Tachyarrhythmias Lasting Longer Than 30 Seconds During the First 24 Months After the run-in Phase (2 Months)
Time frame: within first 24 months after a 2-month run-in phase
Percentage of Procedural Success
Procedural success was determined on the day of the procedure (Day 0) and was based on responses to the following: 1. "Has a validation of the lesions been performed by taking 3 points inside each circular lesion?" 2. "If YES to #1, did you observe that none of them exceed 0.1 mV?" 3. "Did you observe any adverse event during the procedure?" If the answers to (1 ) and (2 ) were YES and (3) was NO, then the procedure was determined a success.
Time frame: The day of the procedure
Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase
Time frame: day 61 through 790
Percentage of Participants Achieving Clinical Success (Subjects Taking AADs That Remain Free From Any Tachyarrhythmias) in Association With Antiarrhythmic Drugs
Time frame: at 26 months and at each patients last follow-up visit
Quality of Life
Time frame: at 14, 26 and 38 months
Health-economics Parameters (Days of Hospitalization)
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Time frame: at 26 months and at each patients last follow-up visit
Percentage of Participants With Normal Sinus Rhythm at the Last Follow-up Visit Measured by ECG and 24-hour Holter Monitor
Time frame: at each patients last follow-up visit