A study to evaluate the safety and effectiveness of the Medtronic Arctic Front™ cryoablation system for treating drug-refractory, symptomatic, persistent atrial fibrillation.
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 pulmonary vein isolation (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.1
54.8%
Primary effectiveness endpoint met
Primary efficacy endpoint of 54.8% exceeded prespecified performance goal (P < 0.001).
0.6%
Primary safety endpoint met
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.
121
minutes
Efficiency outcomes
Short and predictable procedure times of 121 ± 46 minutes
86.8% 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
| Pre-procedure | Blanking period 6W | 3 months | 6 months | 12 months | |
|---|---|---|---|---|---|
| Weekly and symptomatic tele-ECG monitoring | ➜ | ➜ | ➜ | ||
| Telephone follow-up | ◾ | ||||
| In-office 12-lead ECG | ◾ | ◾ | ◾ | ||
| In-office 24-hour Holter | ◾ | ◾ | |||
| Quality-of-life survey | ◾ | ◾ | ◾ |
Access detailed product information, including specification sheets, videos, and presentations.
The Arctic Front Advance Pro™ enables pulmonary vein isolation (PVI) using an anatomical approach during atrial fibrillation (AF) catheter ablation procedures.
The Arctic Front Advance™ over-the-wire balloon catheter is designed to enable pulmonary vein isolation (PVI) during atrial fibrillation ablation procedures.
The Freezor™ cardiac cryoablation catheters are single-use catheters designed to ablate cardiac tissue by creating focal lesions.
The Nitron CryoConsole™ cardiac cryoablation system houses electrical and mechanical components as well as software used for cryotherapy procedures.
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