Cardiac ablation and mapping
STOP AF trial
The STOP AF trial and STOP AF post-approval study (PAS) assessed the safety and effectiveness of the Arctic Front™ and Arctic Front Advance™ cardiac cryoablation catheters.
Trial purpose and design
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 United States.1
Key findings
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.
Trial recurrence monitoring
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 |
|
◾ |
◾ |
PAS purpose and design
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.
PAS key findings
Results demonstrate Arctic Front Advance™ cryoballoon safety, efficacy, and suggest lesion durability in patients with drug-refractory, recurrent, symptomatic PAF.
Primary effectiveness endpoint met
1. Freedom from AF
- 12 months: 81.6%
- 24 months: 73.8%
- 36 months: 68.1%
2. Freedom from AF/AFL/AT
- 12 months: 79.0%
- 24 months: 70.8%
- 36 months: 64.1%
5.8% major complication event rate, of which 3.2% (11/344) phrenic nerve injury (PNI) present post-ablation, 0.3% (1/344) persisted beyond 36 months.
Primary effectiveness
Freedom from AF recurrence at 36 months (N = 90)
PAS recurrence monitoring
|
3 months |
6 months |
12 months |
Annual visit through 36 months |
|---|---|---|---|---|
Electrocardiogram |
◾ |
◾ |
◾ |
◾ |
Clinical follow-up |
◾ |
◾ |
◾ |
◾ |
24-hour Holter monitor |
|
◾ |
|
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48-hour Holter monitor |
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|
◾ |
◾ |
Educational resources on Medtronic Academy
Access detailed product information, including specification sheets, videos, and presentations.
Related products
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Arctic Front Advance Pro™ cardiac cryoablation catheterThe Arctic Front Advance Pro™ enables pulmonary vein isolation (PVI) using an anatomical approach during atrial fibrillation (AF) catheter ablation procedures.
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