Medtronic announced the first patient was enrolled in the Fire and Ice clinical trial, which is a prospective, randomised, multinational head-to-head 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.
Results from the trial, expected in 2014, could potentially 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.
“Through this rigorously designed study, we hope to further validate the long-term treatment benefits associated with cryoballoon ablation,” said 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.”
The largest clinical study to date to compare two atrial fibrillation ablation devices, the Fire and Ice trial will enrol up to 572 patients from up to 20 medical centres throughout Europe. Patients participating in the study must be diagnosed with symptomatic paroxysmal atrial fibrillation and must have failed at least one antiarrhythmic drug. 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. 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.
The numerous short- and long-term benefits of the Arctic Front system have been well established via numerous studies, as well as in the clinical setting, with more than 20,000 successful procedures conducted to date. According to data from the pivotal STOP AF (Sustained treatment of paroxysmal atrial fibrillation) trial, on which the FDA approval of the Arctic Front cardiac cryoablation system was based, 69.9% of patients treated with the innovative technology were free from atrial fibrillation at one year, compared to 7.3% of patients treated with drug therapy only. Patients enrolled in the study displayed a significant reduction of symptoms, a decrease in the use of antiarrhythmic drug therapy and substantial improvements in both physical and mental quality of life factors. The study also demonstrated that treatment with the device is safe, with limited serious procedure-related adverse events (3.1%).
“Medtronic is committed to building upon a strong foundation of scientific evidence to help inform physicians’ clinical decisions and help them select technologies that are best suited for their individual patients,” said Reggie Groves, vice president and general manager of Medtronic’s AF Solutions business. “We look forward to further confirming – via this large-scale, multicentre trial – that our novel cryoballoon ablation technology offers a compelling alternative to radiofrequency ablation.”