Medtronic has enrolled its first patient in the Fire and Ice clinical trial, which is designed to compare the long-term safety, effectiveness and ease of use of the Medtronic Arctic Front cardiac cryoablation system with the Biosense Webster CARTO system guided THERMOCOOL catheter in treating patients with symptomatic paroxysmal atrial fibrillation.
The prospective randomised multinational head-to-head clinical trial will enrol up to 572 patients diagnosed with symptomatic paroxysmal atrial fibrillation and who have failed at least one anti-arrhythmic drug from up to 20 medical centres throughout Europe.
The primary endpoint of the trial is the absence of atrial arrhythmias without anti-arrhythmic drug therapy and without persistent procedure-related serious adverse events, while secondary endpoints 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.
The study results, which are expected in 2014, could impact atrial fibrillation treatment guidelines by providing further clinical evidence regarding the benefits of the Arctic Front system in treating a largely underserved patient population.
Asklepios Klinik St Georg, Hamburg, Germany, cardiology director and principal investigator Karl-Heinz Kuck said the Arctic Front system's good safety and efficacy profile, combined with its straightforward simplicity, has the potential to become the standard of care in treating paroxysmal atrial fibrillation. "Through this rigorously designed study, we hope to further validate the long-term treatment benefits associated with cryoballoon ablation," he added.
The pivotal sustained treatment of paroxysmal atrial fibrillation (STOP AF) trial showed that 69.9% of patients treated with Arctic Front cardiac cryoablation system were free from atrial fibrillation at one year, compared with 7.3% of patients treated with drug therapy only.
Medtronic AF Solutions business vice-president and general manager Reggie Groves said the company looks forward to further confirming through this large-scale multicentre trial that its cryoballoon ablation technology offers a compelling alternative to radiofrequency ablation.
Caption: Medtronic World Headquarters, Fridley, Minnesota. Image courtesy of Bobak Ha'Eri.