The purpose of this study is to evaluate the efficacy and safety of two catheter-based treatment strategies for patients with persistent Atrial Fibrillation (AF) in the long-term period, using implantable ECG recording devices.

Materials and Methods: Patients with persistent AF were included in the study. The primary efficacy endpoint during follow-up time was the first documented event (recurrence of AF, occurrence of atrial flutter, or atrial tachycardia greater than 30 seconds) after a 90-day blanking period. The primary safety endpoint was defined as death, cerebrovascular event, or serious treatment-related complications.

Results: The study included 127 patients with a persistent AF in the last 6 months before inclusion in the study. By random assignment, 50 patients were included in gr 1 and underwent Cryoballoon Ablation (CBA), using a 2nd generation

cryoballoon. Also included in gr 2 are 50 patients who underwent Radiofrequency Ablation (RFA), where a catheter with contact force control was used. All patients had subcutaneous long-term ECG recording devices (Reveal XT, Medtronic) implanted postoperatively. The mean duration of follow-up was 36 months. The primary efficacy endpoint occurred in 15 patients in the cryoballoon ablation group and in 14 patients in the radiofrequency ablation group (Kaplan-Meier survival estimates, 30% and 28%, respectively; hazard ratio, 0.96; 95% confidence interval).

Conclusions: The primary efficacy was similar in the study groups, still in the long-term period, the superiority of RFA using a catheter with contact force control was noted, but the difference in results was statistically no significant (p < 0.672), and there was no significant difference between the two methods with regard to overall safety.