Cardiac ablation and mapping

STOP AF trial

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.

Alert Indications, Safety, and Warnings
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Study 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 U.S.1

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Arctic Front cryoballoon encircled on a gray background

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.  

Study recurrence monitoring

Day 0 blanking period for AF detection

3 months

6 months

12 months

Weekly and symptom-initiated TTM

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Electrocardiogram

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Clinical follow-up

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48-hour Holter monitor

 

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PAS study 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.

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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: 82.2%
  • 24 months: 75.3%

2. Freedom from AF/AFL/AT

  • 12 months: 79.5%
  • 24 months: 72.3%

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)

Graph that illustrates the primary effectiveness of the Arctic Front cryoballoon to treat atrial fibrillation (AF)

PAS recurrence monitoring

 

3 months

6 months

12 months

Annual visit through 36 months

Electrocardiogram

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Clinical follow-up

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24-hour Holter monitor

 

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48-hour Holter monitor

 

 

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*

Failed one or two of the following three antiarrhythmic drugs: flecainide, propafenone, sotalol.

References

1

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.

2

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).