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Arctic Front Advance

Cardiac CryoAblation Catheter

Clinical Studies and Outcomes

  

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Stop AF

Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) Trial Confirms the Safety and Effectiveness of Arctic Front1

Objective

  • To confirm the safety and effectiveness of the Arctic Front system when used to treat patients with drug refractory Paroxysmal Atrial Fibrillation (PAF)

Methods

  • Patients with drug-refractory paroxysmal atrial fibrillation
  • Failure of 1 or 2 antiarrhythmic drugs (flecainide, propafenone, and sotalol)
  • Total of 245 patients randomized 2:1 to cryoablation or AF medication
  • 26 centers in the United States and Canada
  • Safety and effectiveness follow-up conducted at 12 months
  • Patients followed via weekly and symptom initiated transtelephonic monitoring, periodic electrocardiogram, clinical follow-up at 1, 3, 6, 9 and 12 months and 24-hour Holter at 6 and 12 months


Primary Safety End Points Achieved

Cryoablation Procedure Events*
Defined as a subset of device or procedure- related serious adverse events.

Safety and Effectiveness with Arctic Front Cardiac CryoAblation Catheter

Major AF Events**
Defined as which were serious adverse events related to atrial fibrillation.

Safety and Effectiveness with Arctic Front Cardiac CryoAblation Catheter


Primary Effectiveness End Points Achieved

69.9% achieved treatment success at 12 months

Safety and Effectiveness with Arctic Front Cardiac CryoAblation Catheter


* CPEs were device- or procedure-related serious adverse events (SAE) categorized as access site complications, cardiac damage, pulmonary vein (PV) stenosis, embolic complications, arrhythmias, unresolved phrenic nerve palsy, and death.
** MAFEs were serious adverse events categorized as cardiovascular death, myocardial infarction, stroke, or hospitalization for AF recurrence/ablation, flutter ablation, embolic events, heart failure, hemorrhage or antiarrhythmic drug treatment

 

Reference

1

Medtronic Inc., Arctic Front Cardiac CryoAblation Catheter clinical reports, in support of FDA premarket approval.

Arctic Front Advance Data