Cardiac ablation and mapping 

Fire and Ice trial

This study compares the efficacy and safety of pulmonary vein isolation (PVI) using Arctic Front™ cryoballoon versus radiofrequency ablation. 

Healthcare professional in protective gear and scrubs washing hands and arms thoroughly with soap and water

Study purpose and design

The Fire and Ice AF ablation clinical trial is the largest, prospective, 1:1 randomized, non-inferiority study (762 patients from 16 sites in 8 countries) that compared the efficacy and safety of PVI using cryoballoon versus radiofrequency (RFC) ablation in patients with paroxysmal atrial fibrillation (PAF).1

Arctic Front cryoballoon encircled on a gray background

Key findings

Pulmonary vein isolation by means of cryoballoon ablation was non-inferior to pulmonary vein isolation by radiofrequency ablation in terms of efficacy and safety.

Primary effectiveness endpoint met

The cryoballoon met the non-inferiority endpoint and did so with shorter and more consistent procedure times compared to radiofrequency (60%).2

Primary safety endpoint met

The primary safety endpoint was achieved. There was no significant difference between the two methods with regard to overall safety.

Freedom from primary failure event
Homogeneity test across all groups: p = 0.25

Chart showing the freedom from a primary failure event since a cryoballoon ablation procedure

Primary safety endpoint
Hazard ratio, 0.78 (95% CI, 0.52–1.18) p = 0.24

Chart showing the primary safety endpoint of a cryoballoon ablation procedure

Secondary analyses

In a predefined secondary analysis, relative to radiofrequency, the Arctic Front™ cryoballoon demonstrated significant improvements.3

34% fewer cardiovascular hospitalizations

  • Cryo: 139 events in 89 subjects (89/374; 23.8%)
  • RFC: 203 events in 135 subjects (135/376; 35.9%)

33% fewer repeat ablations

  • Cryo: 49 events in 44 subjects (44/374; 11.8%)
  • RFC: 70 events in 66 subjects (66/376; 17.6%)



Health economics analysis

  • 96% of the total cost savings was due to fewer repeat ablations and atrial fibrillation-related hospitalizations.4
  • Overall payer costs were significantly lower in the cryoballoon group compared to the radiofrequency group (RFC) across three healthcare systems.

Total cost per patient differences (U.S. CMS perspective)
Trial period payer cost; average follow-up: 18 months

Chart of cost per patient differences between the Arctic Front cryoballoon versus radiofrequency ablation in clinical trial

Endpoint definitions

Primary efficacy endpoint

Time to first documented recurrence of AF > 30s/AT/AFL, prescription of AAD, and/or repeat ablation

Primary safety endpoint

Time to first all-cause death, all-cause stroke/TIA or treatment-related serious adverse events (AE)

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Fürnkranz A, Brugada J, Albenque JP, et al. Rationale and design of FIRE AND ICE: a multicenter randomized trial comparing efficacy and safety of pulmonary vein isolation using a cryoballoon versus radiofrequency ablation with 3D-reconstruction. J Cardiovasc Electrophysiol. 2014;25(12):1314–1320.


Kuck KH, Brugada J, Fürnkranz A, et al. Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation. N Engl J Med. 2016;374(23):2235–2245.


Kuck KH, Fürnkranz A, Chun KRJ, et al. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016;37(38):2858–2865


Chun KRJ, Brugada J, Elvan J, et al. The impact of cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation on healthcare utilization and costs: an economic analysis from the FIRE AND ICE trial. J Am Heart Assoc. 6(8):e006043.