Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation

Key inclusion criteria:

• A diagnosis of recurrent symptomatic paroxysmal or persistent AF

• Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III

Key exclusion criteria:

• 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 lastthree months

• Any cardiac surgery within the previous six months

• Prior left atrial ablation or surgical procedure

• Presence of an implanted cardiac device

• Body mass index (BMI) >40 kg/m^2

• Left ventricular ejection fraction (LVEF) <35%

• Anterior-posterior left atrial (LA) diameter >55mm