Your browser is out of date
With an updated browser, you will have a better Medtronic website experience. Update my browser now.
Cardiac ablation and mapping
The STOP AF trial and STOP AF post-approval study assessed the safety and effectiveness of the Arctic Front™ and Arctic Front Advance™ cardiac cryoablation catheters.
The Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) trial was 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 paroxysmal atrial fibrillation (PAF). Outcomes of this trial resulted in FDA approval of the cryoballoon in the U.S.1
69.9%
Primary effectiveness endpoint met
The STOP AF trial demonstrated that cryoballoon ablation is a safe and effective alternative to antiarrhythmic medication for the treatment of patients with symptomatic paroxysmal AF.
3.1%
Primary
safety
endpoint met
The first-generation cryoballoon trial showed improved safety outcomes relative to drugs. 3.1% major AF events in the ablation arm compared to the drug arm, which had 8.5% major AF events.
Day 0 blanking period for AF detection |
3 months |
6 months |
12 months |
---|---|---|---|
Weekly and symptom-initiated TTM |
➜ | ➜ | ➜ |
Electrocardiogram |
◾ |
◾ |
◾ |
Clinical follow-up |
◾ |
◾ |
◾ |
48-hour Holter monitor |
|
◾ |
◾ |
The STOP AF Post Approval Study (PAS) is the largest prospective FDA multicenter study in North America to assess long-term safety and effectiveness of the Arctic Front Advance™ cardiac cryoablation catheter system in the treatment of patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation.2 The primary objectives are effectiveness (freedom from AF) at 36 months and safety (cryoablation/procedure-related events) at 12 months.
Results demonstrate Arctic Front Advance™ Cryoballoon safety, efficacy, and suggest lesion durability in patients with drug-refractory, recurrent, symptomatic PAF.
5.8% adverse event rate, of which 3.2% (11/344) PNI unresolved at hospital discharge, 0.3% (1/344) ongoing ≥ 24 months post-ablation.
Primary effectiveness
Freedom from AF at 24 months (N = 344)
|
3 months |
6 months |
12 months |
Annual visit through 36 months |
---|---|---|---|---|
Electrocardiogram |
◾ |
◾ |
◾ |
◾ |
Clinical follow-up |
◾ |
◾ |
◾ |
◾ |
24-hour Holter monitor |
|
◾ |
|
|
48-hour Holter monitor |
|
|
◾ |
◾ |
Access detailed product information, including spec sheets, videos, and presentations.
Failed one or two of the following three antiarrhythmic drugs: flecainide, propafenone, sotalol.
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. 2013;61(16):1713–1723.
Knight B, et al. Second Generation Cryoballoon Ablation in Paroxysmal Atrial Fibrillation Patients: 24 Month Safety and Efficacy from the STOP-AF Post Approval Study. Presented at HRS 2017 (Abstract).