Trial Design1,2

FIRE AND ICE Trial (NCT01490814)

The FIRE and ICE Trial is the largest multicenter, controlled, prospective, 1:1 randomized, non-inferiority, parallel-group, open, and blinded endpoints assessment study to date comparing the efficacy and safety of pulmonary vein isolation using Arctic Front catheters versus ThermoCool® point-by-point radiofrequency catheters with CARTO® 3D mapping system in patients with paroxysmal atrial fibrillation.

Study Population

762 subjects randomized 1:1 at 16 sites in 8 countries

Key inclusion criteria:

  • Symptomatic paroxysmal atrial fibrillation (PAF) with ≥ 2 episodes and ≥ 1 episode documented within the last 12 months
  • Documented treatment failure of ≥ 1 antiarrhythmic drug (class I or III AAD)

Key exclusion criteria:

  • Previous LA ablation or surgery PCI, MI within 3 months of enrollment
  • Stroke/TIA within 6 months of enrollment
  • LVEF < 35%
  • LA diameter > 55 mm

Efficacy Endpoints

Time to first documented recurrence of atrial fibrillation (AF) > 30 sec/atrial tachycardia (AT)/atrial flutter (AFL) or prescription of AAD or re-ablation, whichever comes first (a blanking period of 3 months was maintained after the initial procedure)

Safety Endpoints

Primary safety outcome parameter: a composite of all-cause death, all-cause stroke/transient ischemic attack (TIA) and serious treatment related adverse events.

Secondary Analyses

  • Procedure and fluoroscopy time*
  • Sites reported time to first and number of all-cause hospitalization, including: Cardiovascular-related hospitalizations* (including AF hospitalizations†), repeat ablations,* and direct current cardioversions (DCCV)
  • Hospitalizations defined as a prolonged stay of ≥ 2 nights post index ablation or in-patient stay not concurrent with index procedure of ≥ 1 calendar day
  • Quality of life* was assessed every 6 months using the SF-12 and EQ-5D-3L

*Protocol defined secondary outcome
† Not predefined but included in analyses

Randomization Chart

Weekly Symptomatic Table

References

  1. Fürnkranz A, et al. J Cardiovasc Electrophysiol. 2014;25:1314-1320.
  2. Kuck KH, et al. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016; 374(23): 2235-45.