Medtronic initiates STOP Persistent AF clinical trial using the Arctic Front Advance Cardiac CryoAblation Catheter to treat persistent atrial fibrillation.

Medtronic plc announced first enrollments in the STOP Persistent AF clinical trial. The trial will evaluate the safety and effectiveness of a pulmonary vein isolation-only (PVI) strategy for treating patients with persistent atrial fibrillation (AF), using the Arctic Front Advance Cardiac CryoAblation Catheter. John Harding, M.D., Doylestown Hospital in Doylestown, Penn., treated the first patient enrolled in the trial.

STOP Persistent AF is a prospective, multicenter, single-arm clinical trial that will enroll up to 225 patients at 25 centers in the United States, Canada, Europe and Japan. Patients will be followed for 12 months after the initial cryoballoon ablation procedure. Recently updated guidelines published by the European Society of Cardiology (ESC) acknowledge cryoablation therapy for AF, and recognize PVI as an effective and preferred treatment option for select patients with AF. The Medtronic cryoballoon has been used in more than 250,000 cases worldwide. Currently, no ablation catheters are approved for treating persistent AF in the United States. The Medtronic Arctic Front Advance Cryoablation System is approved in the U.S. for the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation and in Europe for the treatment of atrial fibrillation.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.

Comment: The device is a catheter-delivered balloon that emits coolant from within, presenting a large, uniform cold surface that reduces the need for surgeons to isolate pulmonary veins when treating paroxysmal atrial fibrillation. Medtronic says its system is far more efficient than radiofrequency devices, working faster and treating more complicated anatomies than its competitors. In data submitted to the FDA, 73% of patients treated with Arctic Front Advance were free of AF in a one-year follow up, a clinically significant increase over radiofrequency treatment and standard drug therapy.

Comment: Arctic Front Advance Cardiac CryoAblation Catheter was FDA approved in 2012 and indicated for indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation.