The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).
Subjects planned for an AF catheter ablation procedure, with a documented history of AF.
Diagnosis must be confirmed within 12 months before enrollment.
(Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation
Subjects between 18 and 75 years of age, inclusive
Patients who have contraindications to open heart surgery
Patients from an Intensive Care Unit
Patients with active systemic infection (sepsis)
Patients who have had previous ablation in the left or right atrium
Single group
Globe Mapping and Pulsed Field Ablation System (Globe PF System)
DeviceDuring the procedure, the Globe Catheter will be delivered via standard femoral vein access and transseptal puncture. Anatomical and electrophysiological mapping of the left atrium (LA) will be followed by pulsed field ablation (PFA) to achieve pulmonary vein isolation (PVI). Additional PFA or radiofrequency (RF) ablation lesions may be created as deemed appropriate by the Investigator. Intracardiac electrogram mapping with the Globe PF System will be used to confirm PVI.
Rate of subjects presenting with primary safety events which are device- or procedure-related
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