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Patient enrollment begun for trial of cryoballoon ablation in persistent AF
The first patients have been enrolled in a new trial to study the safety and efficacy of a pulmonary vein isolation-only strategy using a cryoballoon ablation procedure in patients with persistent atrial fibrillation, according to a press release from Medtronic.
The study, STOP Persistent AF, is a prospective, single-arm trial that will assess performance of a cardiac cryoablation catheter (Arctic Front Advance, Medtronic). The researchers aim to enroll up to 225 patients across 25 centers in the United States, Canada, Europe and Japan. Participants will be followed up for 1 year.
“Gaining meaningful data from this trial will help further clinicians' understanding of possible treatment options for patients with persistent AF," Hugh Calkins, MD, director of the Electrophysiology Laboratory and Arrhythmia Service at the Johns Hopkins Hospital, Baltimore, said in the release. "As AF progresses and episodes become more constant, patients' quality of life diminishes while their risk of AF-related health effects, such as [HF] and stroke, increases. This trial could help us advance care for this hard-to-treat population."
Pulmonary vein isolation is recognized as the preferred treatment for select patients with AF according to recently updated guidelines from the European Society of Cardiology; however, there are currently no ablation catheters approved for treating persistent AF in the U.S., according to the release.