The STOP Persistent AF trial was the first and largest FDA-regulated, prospective, multicenter, single-arm clinical trial to assess the safety and efficacy for treating symptomatic persistent Afib patients who have failed drug treatment using the Arctic Front Advance™ Cryoballoon. The trial included 165 patients treated at 25 sites across the United States, Canada, and Japan. FDA approval was based on 150 patients treated in the United States.
The Arctic Front Advance Cardiac Cryoablation Catheter is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal and persistent atrial fibrillation (episode duration less than 6 months).
Treatment with the cryoballoon was proven to be safe and effective.
Arctic Front Advance Pro Cryoballoon
The study demonstrated that patients experienced a significant improvement in their quality of life and Afib-related symptoms and a reduction in antiarrhythmic drug use after cryoablation. The graph below reflects data from the entire 165-patient population from the study.
Of the entire 165 patients treated in the study, 86.8% of patients did not require a repeat ablation.1
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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.