Overview
This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF).
Eligibility
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 last three 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