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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

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This is an image of the 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

Freedom from primary failure event

Homogeneity test across all groups: p = 0.25

This chart shows the freedom from a primary failure event since a cryoballoon ablation procedure.

Primary safety endpoint met

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

Primary safety endpoint

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

This chart shows 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

This is a chart showing the cost per patient differences between the Arctic Front™ cryoballoon group and the radiofrequency group of the Fire and Ice AF ablation 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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