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Objectives STOP AF PAS (Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study) is the first prospective, multicenter, 3-year study in North America to assess long-term safety and effectiveness of the cryoballoon for treatment of patients with drug-refractory symptomatic pAF. Background The STOP AF PAS was required by the U.S. Food and Drug Administration at the time of approval of the first-generation cryoballoon for the treatment of paroxysmal atrial fibrillation (pAF). The second-generation cryoballoon (CB2) was commercially released shortly after this trial was initiated. Methods The study was nonrandomized. Enrollment was completed with 344 eligible patients undergoing pulmonary vein isolation (PVI) using the CB2. Procedure-related safety and freedom from AF and symptomatic atrial flutter/atrial tachycardia through 3 years were determined. Documented atrial arrhythmias ≥30 s were considered treatment failures. Results Acute PVI was achieved in 99.3% (1,341 of 1,350) of veins. Mean follow-up was 34 ± 7 months. The rate of major complications was 5.8%, including a 3.2% rate of phrenic nerve injury, which resolved in all but 1 patient by 36 months. At 36 months, 11.7% of patients were prescribed antiarrhythmic agents, inclusive of “pill-in-the-pocket” administration. Freedom from AF was 81.6% at 12 months, 73.8% at 24 months, and 68.1% at 36 months. Freedom from AF and symptomatic atrial flutter/atrial tachycardia was 79.0% at 12 months, 70.8% at 24 months, and 64.1% at 36 months. Freedom from a repeat ablation procedure was 80.9% at 36 months. Conclusions PVI using the CB2 was an effective treatment for patients with pAF, with freedom from all atrial arrhythmias of 64% at 36 months. (Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study [STOP AF PAS]; NCT01456949)

This trial will significantly advance our understanding of the prognostic and therapeutic usefulness of electrophysiologic studies in patients with coronary artery disease. Several features of this trial are worth emphasizing. First, the protocol for performing programmed stimulation and serial drug testing is designed to mirror those currently in use by many practicing electrophysiologists. While practice patterns vary, the procedures used in the trial reflect what is considered "usual and standard" practice. Second, because half of the patients with inducible sustained ventricular tachycardia will be given no antiarrhythmic therapy, we will be able to ascertain the true risk of sudden death in this patient population without the influence of these agents. Third, this trial will assess the usefulness of a method of guiding antiarrhythmic therapy (electrophysiologic testing) to reduce mortality in this high-risk population. It will not evaluate the efficacy of a specific type of antiarrhythmic therapy.

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