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The STOP Persistent AF trial is the first and largest, prospective, multicenter, single-arm study with prespecified performance goals to assess the safety and efficacy of PVI using the Medtronic Arctic Front Advance™ Cryoballoon for patients with drug-refractory, symptomatic, persistent AF. The trial included 165 patients treated at 25 sites across the United States, Canada, and Japan.
Primary safety endpoint rate of 0.6% was below prespecified performance goal (P = 0.002). Only one primary safety event occurred and was unrelated to study device.
Primary efficacy endpoint of 54.8% exceeded prespecified performance goal (P < 0.001).
Short and predictable procedure times of 121 ± 46 minutes
Secondary endpoint assessments of quality of life demonstrated significant improvements by 12 months post-ablation (P < 0.001) with a high rate of freedom from repeat ablation (86.8%).
Success at 12 months > 40% performance goal
Safety event rate < 13% performance goal
Su WW, Reddy VY, Bhasin K, et al. Cryoballoon Ablation of Pulmonary Veins for Persistent Atrial Fibrillation: Results From the Multicenter STOP Persistent AF Trial. Heart Rhythm. Published online June 23, 2020.