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FIRE AND ICE – fry or freeze for AF?

Enrolment continues enthusiastically for the recently launched FIRE AND ICE trial. This is a multinational clinical trial comparing the long-term safety, effectiveness and ease of use of the Medtronic Arctic Front® Cardiac CryoAblation System compared to the Biosense Webster CARTO® System Guided THERMOCOOL® Catheter to treat patients with symptomatic paroxysmal atrial fibrillation.

The largest clinical study to date to compare two atrial fibrillation ablation devices, the FIRE AND ICE trial will enroll up to 572 patients from up to 20 medical centers throughout Europe. Patients participating in the study must be diagnosed with symptomatic paroxysmal atrial fibrillation and must have failed at least one antiarrhythmic drug.

Final results expected in November 2014.  These could potentially impact atrial fibrillation treatment guidelines, organizers  by providing further clinical evidence regarding the benefits of the cryoablation system in treating a largely underserved patient population. FIRE AND ICE is an independent investigator initiated clinical trial, supported by Medtronic as an External Research Program.

Participants will be followed for an average of one year after initial ablation. The primary endpoint of the trial is the absence of atrial arrhythmias without antiarrhythmic drug therapy and without persistent procedure-related serious adverse events such as strokes, pulmonary vein stenosis and phrenic nerve injury at six and 12 months following ablation.

Professor Karl-Heinz Kuck

Professor Karl-Heinz Kuck

Key secondary endpoints that will be assessed include procedural data (total procedure duration, time of fluoroscopy and duration of hospital stay), quality of life, sedation and the need for atrial flutter ablation.

“Through this rigorously designed study, we hope to further validate the long-term treatment benefits associated with cryoballoon ablation,” said Dr Karl-Heinz Kuck, principal investigator and director of cardiology, at Asklepios Klinik St. Georg (Hamburg, Germany). “Given the Arctic Front system’s clinically robust safety and efficacy profile, combined with its straightforward simplicity, this innovative medical technology has the potential to become the standard of care in treating paroxysmal atrial fibrillation”.

Trial design

Published on: April 18, 2012

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ENDORSED BY

  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association
 

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