Medtronic has enrolled the first participants in the STOP Persistent AF clinical trial. The trial will evaluate the safety and effectiveness of a pulmonary vein isolation-only strategy for treating patients with persistent atrial fibrillation (AF), using the Arctic Front Advance cardiac cryoablation catheter. John Harding, Doylestown Hospital in Doylestown, USA, treated the first patient enrolled in the trial.
STOP Persistent AF is a prospective, multicentre, single-arm clinical trial that will enrol up to 225 patients at 25 centres in the USA, Canada, Europe and Japan. Patients will be followed for 12 months after the initial cryoballoon ablation procedure.
“Gaining meaningful data from this trial will help further clinicians’ understanding of possible treatment options for patients with persistent AF,” says co-principal investigator Hugh Calkins, director of the Electrophysiology Laboratory and Arrhythmia Service at the Johns Hopkins Hospital in Baltimore. “As AF progresses and episodes become more constant, patients’ quality of life diminishes while their risk of AF-related health effects, such as heart failure and stroke, increases. This trial could help us advance care for this hard-to-treat population.”
Recently updated guidelines published by the European Society of Cardiology (ESC) acknowledge cryoablation therapy for AF, and recognise pulmonary vein isolation 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 USA. The Medtronic Arctic Front Advance cryoablation system is approved in the USA for the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation and in Europe for the treatment of atrial fibrillation.