Study Design and Date
First randomized, multicenter trial comparing antiarrhythmic drug therapy and cryoballoon ablation.
Designed to confirm the safety and effectiveness of the first-generation Arctic Front™ Cardiac Cryoablation System when used to treat patients with drug-refractory, recurrent symptomatic PAF.
Number of Patients
Enrolled 245 patients across 26 centers.
Results showed 69.9% of patients treated with Arctic Front were free from AFib at one year, compared to 7.3% of patients treated with drug therapy only.
The study also showed cryoballoon ablation is safe and provides statistically significant improvements in quality of life.
Outcomes of this trial led to FDA approval of cryoballoon ablation.
Packer DL, Kowal RC, Wheelan KR, et al. Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: first results of the North American Arctic Front (STOP AF) pivotal trial. J Am Coll Cardiol. April 23, 2013;61(16):1713-1723.