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

Abstract

Background: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia imposing substantial morbidity and mortality. Catheter-based pulmonary vein isolation (PVI) using radiofrequency current (RFC) has become a standard treatment for drug-resistant and symptomatic paroxysmal AF (PAF). In recent years, the cryoballoon-based technique is increasingly used as a promising alternative with a short learning curve.

Methods: The FIRE AND ICE trial is a prospective, randomized, controlled, open, blinded outcome assessment, noninferiority trial comparing cryoballoon-, and RFC-based PVI. Patients with drug-resistant PAF will be randomized in a 1:1 matrix in multiple European centers. The primary hypothesis is that cryoballoon ablation is not inferior to RFC ablation using 3-dimensional mapping with respect to clinical efficacy. The primary endpoint is defined as the time to first documented clinical failure, including: (1) recurrence of AF; (2) atrial flutter or atrial tachycardia; (3) prescription of class I or III antiarrhythmic drugs; or (4) re-ablation, whichever comes first, following a blanking period of 3 months after the index ablation procedure. The primary safety endpoint is a composite of death, stroke/transient ischemic attack, cardiac arrhythmias (apart from AF recurrence) causally related to the therapeutic intervention, and procedure-related serious adverse events.

Conclusion: The FIRE AND ICE trial compares 2 different technologies to perform catheter ablation of PAF with respect to efficacy and safety. It aims at providing objective data to guide selection and usage of ablation catheters in the treatment of AF.

Trial registration: ClinicalTrials.gov NCT01490814.

Keywords: atrial fibrillation; catheter ablation; cryoballoon; electrophysiology; radiofrequency ablation.