Evaluation of the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal Atrial Fibrillation (PULSAR PAS)

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

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