First patients enrolled in Medtronic’s STOP AF First cryoballoon clinical trial

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Medtronic’s Arctic Front Advance cryoballoon

The first participants have been enrolled in Medtronic’s STOP AF First clinical trial. The trial will evaluate the safety and effectiveness of performing pulmonary vein isolation (PVI) with the Arctic Front Advance cryoballoon in patients with symptomatic paroxysmal atrial fibrillation (AF) prior to treatment with antiarrhythmic medications.

The first patient in the trial was enrolled at The Ohio State University Wexner Medical Center, Columbus, USA, by Jaret Tyler.

STOP AF First is a prospective, interventional, multicentre, randomised, controlled, clinical trial that will enrol up to 210 patients at up to 30 sites in the USA. Patients will be randomised to cryoballoon ablation (treatment arm) or antiarrhythmic drug (AAD) therapy (control arm), and followed for 12 months. Oussama Wazni, co-director of the Atrial Fibrillation Center at the Cleveland Clinic, Cleveland, USA, serves as the study’s national principal investigator.

“Clinical research shows that about half of patients with symptomatic AF do not respond to antiarrhythmic drugs, leading to recurrence,” says Colleen Fowler, vice president and general manager of the AF Solutions business, part of the Cardiac and Vascular Group at Medtronic. “As AF progresses, it becomes more difficult to treat, and has lower long-term success rates. With the number of AF patients expected to increase exponentially in the coming years, this trial will help ascertain whether earlier treatment with the cryoballoon can improve outcomes for a greater number of patients.”

Cryoballoon ablation is used in a minimally invasive procedure to isolate the pulmonary veins, which are a source of erratic electrical signals that cause AF. The device uses cold energy (freezing) rather than heat (radiofrequency) to create scar tissue and interrupt irregular electrical pathways in the heart.

The 2016 European Society of Cardiology’s (ESC) guidelines and the recent 2017 Heart Rhythm Society (HRS) Consensus Statement for the management of atrial fibrillation both acknowledge cryoablation therapy as an appropriate ablation energy for treating AF, and recognise PVI as an effective and preferred treatment option for select patients with AF.

In the USA, first-line treatment of symptomatic paroxysmal AF with the Arctic Front Advance cryoablation system is investigational use only; the system is approved in the USA for the treatment of drug refractory, recurrent, symptomatic paroxysmal AF, and in Europe for the treatment of atrial fibrillation. More than 250,000 patients in more than 50 countries worldwide have been treated with the cryoballoon.

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