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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
549
Ablation and atrial mapping with the Globe Pulsed Field System
Grandview Medical Center
Birmingham, Alabama, United States
St. Bernards Medical Center
Jonesboro, Arkansas, United States
Effectiveness endpoint
Number of subjects with freedom from documented atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT) 12 months post-procedure.
Time frame: 12 months
Safety endpoint
Rate of subjects presenting with one or more of the specified primary safety events within 7 days of the index ablation procedure.
Time frame: 7 days
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