This study will evaluate the long-term safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal atrial fibrillation.
A diagnosis of recurrent symptomatic paroxysmal atrial fibrillation
Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III
Persistent or long-standing persistent atrial fibrillation (continuous atrial fibrillation that is 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
12-month Treatment Success Rate
The rate of 12-month treatment success following ablation procedure using the Globe Pulsed Field System. Treatment success is defined as freedom from treatment failure, where treatment failure includes: * Documented recurrence of atrial fibrillation, atrial flutter, atrial tachycardia (AF/AFL/AT) as evidenced by episodes ≥ 30 seconds on Holter monitoring or equivalent during the effectiveness evaluation period, or by an episode documented on the entire recording of the 12-lead ECG (≥ 10 seconds) at the 12-month evaluation/visit. * Acute procedural failure * Direct current (DC) cardioversion for AF/AFL/AT during the effectiveness evaluation period * Redo ablation failure * Antiarrhythmic drugs (AADs) failure * Surgical treatment for AF/AFL/AT after the index procedure
Primary Safety Event Rate
Rate of subjects presenting with one or more primary safety events up to and including 7 days after the index ablation procedure. Primary safety events comprise the following device- or procedure-related serious adverse events: * Death * Cardiac tamponade/perforation * Heart block * Major vascular access complication * Major bleeding * Myocardial infarction (MI) * Pericarditis requiring intervention * Pulmonary edema * Stroke/cerebrovascular accident (CVA) * Thromboembolism * Transient ischemic attack (TIA) * Vagal nerve injury resulting in gastroparesis * Atrio-esophageal fistula * Diaphragmatic paralysis/phrenic nerve injury * Severe pulmonary vein (PV) stenosis
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