Medtronic has enrolled first patient in its Fire and Ice clinical trial for comparing its Arctic Front Cardiac CryoAblation System with Biosense Webster's Carto System Guided Thermocool Catheter.
The prospective, randomized, multinational head-to-head clinical trial, which will enroll upto 572 patients, will compare the long-term safety, effectiveness and ease of use of its Arctic CryoAblation System to Carto System.
The Arctic Front cryoballoon system freezes and blocks the erratic triggers in symptomatic paroxysmal atrial fibrillation patients and helps the balloon in maintaining contact with the heart tissue during the procedure, allowing for greater catheter stability.
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.
The 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.
Asklepios Klinik principal investigator and cardiology director Karl-Heinz Kuck said given the Arctic Front system’s clinically robust safety and efficacy profile, combined with its simplicity, this medical technology has the potential to become the standard of care in treating paroxysmal atrial fibrillation.
The company said results of this trial are excepted to be displayed in 2014.