The study will evaluate the safety and 12-month effectiveness of the Pulmonary Vein Isolation plus Box Isolation of Fibrotic Areas (BIFA) ablation strategy with the Globe Pulsed Field System (Globe PF System) for the treatment of atrial fibrillation.
A diagnosis of recurrent symptomatic paroxysmal or persistent AF
Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III
Long-standing persistent AF (sustained >12 months)
Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
History of thromboembolic events within the past six months
Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months
Single group
Globe Pulsed Field System
DeviceAblation and atrial mapping with the Globe Pulsed Field System
Effectiveness endpoint
Number of subjects with freedom from documented atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT) 12 months post-procedure.
Safety endpoint
Rate of subjects presenting with one or more of the specified primary safety events within 7 days of the index ablation procedure.
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