title: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Cardioangiologisches Centrum Bethanien, Wilhelm Epstein Strasse, Frankfurt, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Fürnkranz
authors.forename: Josep
authors.initials: J
authors.lastname: Brugada
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Albenque
authors.forename: Claudio
authors.initials: C
authors.lastname: Tondo
authors.forename: Kurt
authors.initials: K
authors.lastname: Bestehorn
authors.forename: Karl
authors.initials: K
authors.lastname: Wegscheider
authors.forename: Feifan
authors.initials: F
authors.lastname: Ouyang
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Kuck
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000601:surgery*; D018780:Body Surface Potential Mapping / Q000379:methods*; D017115:Catheter Ablation / Q000009:adverse effects* / Q000379:methods*; D003452:Cryosurgery / Q000009:adverse effects* / Q000379:methods*; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006801:Humans; D021621:Imaging, Three-Dimensional / Q000379:methods; D008297:Male; D008875:Middle Aged; D012107:Research Design; D016896:Treatment Outcome; D055815:Young Adult
keywords: atrial fibrillation; catheter ablation; cryoballoon; electrophysiology; radiofrequency ablation