Healthcare Professionals

Arctic Front Advance

Cardiac CryoAblation Catheter

Clinical Studies and Outcomes

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


Artic Front Advance Data

Below is a summary of publications on Arctic Front Advance. STOP AF, referenced on the first tab in this section, is the pivotal study supporting the approval of Arctic Front and Arctic Front Advance.

1-YEAR CLINICAL DATA 2-16

Single Procedure Freedom from AF, AT, or AFL

1-YEAR CLINICAL DATA


Footnotes

*

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

Arrhythmia monitoring methods and definition of procedure success (Freedom from AF Only or AF/AT/AFL) varied between studies


References

1

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

2

Packer, 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. 61(16):1713-1723 April 23, 2013;

3

Di Giovanni, et al. J Cardiovasc Electrophysiol. 2014; 25(8):834-9.

4

Fürnkranz, et al. Journal of Cardiovascular Electrophysiology. 2014 ; 25(8):840-4.

5

Aryana, et al. J Interv Card Electrophysiol. 2014;41(2):177-186.

6

Aytemir, et al. Europace. 2015;17(3):379-87.

7

Greiss, et al. PACE. 2015 Jul;38(7):815-24.

8

Metzner, et al. Circ Arrhythm Electrophysiol. 2014; 7(2):288-292.

9

Chierchia, et al. Europace. 2014.

10

Chierchia, et al. J Cardiovasc Electrophysiol. 2015; In Press; 16(5):639-644.

11

Kumar et al. J Interv Card Electrophysiol. 2014;41(1):91-7.

12

Jourda, et al. Europace. 2015;17(2):225-31.

13

Ciconte, et al. Heart Rhythm. 2015;12(4):673-80.

14

Tebbenjohanns, et al. Europace. 2015.

15

Wissner, et al. Europace. 2015 Aug;17(8):1236-40.

16

Aryana A, Singh SM, Kowalski M, et al. Acute and Long-term Outcomes of Catheter Ablation of Atrial Fibrillation Using the Second-Generation Cryoballoon Versus Open-Irrigated Radiofrequency: A Multicenter Experience. J Cardiovasc Electrophysiol. August 2015;26(8):832-839.