Medtronic has reported that it will present pivotal data for the 'Arctic Front' CryoAblation Catheter System at the 59th Annual Scientific Session of the American College of Cardiology. The STOP-AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) clinical trial has been evaluating the safety and efficacy of Arctic Front for paroxysmal atrial fibrillation (AF) patients.
The company said that the system has been approved for use in Europe, Australia and Hong Kong and is under investigational use in the US. Data from the Medtronic-sponsored Connect (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) clinical trial, will also be presented.
The trial has been assessing how the use of the CareLink Network to remotely monitor patients with cardiac resynchronization therapy-defibrillators (CRT-Ds) and implantable cardioverter-defibrillators (ICDs), equipped with Conexus Wireless Telemetry, might effectively enable better patient care and reduce unnecessary healthcare costs.
The primary objective is to demonstrate if the company’s wireless remote management system reduces the time to clinical decision for arrhythmias (abnormal heart rhythms), cardiovascular disease progression, and system issues compared to patients who receive only in-office care.
This pivotal trial studied the safety and efficacy of the Arctic Front CryoAblation Catheter System in paroxysmal AF patients, as compared to drug therapy. Patients were randomized to receive ablation therapy or commonly used anti-arrhythmic drug treatments.
For every three patients enrolled, approximately two received an ablation and one was assigned to the drug therapy group. Over 26 US and Canadian centers enrolled 245 patients, who were followed for 12 months after the ablation procedure. Results are part of a PMA submission in consideration for FDA approval for the Arctic Front CryoAblation Catheter System.