This is a single-arm, open label, clinical outcome study to research the durability (success) of receiving a pulsed field ablation (PFA) per standard of care for treatment of atrial fibrillation during a subsequent procedure for the insertion of a left atrial appendage occlusion (LAAO) device. The reassessment of the initial ablation will be performed with or without additional ablation if needed.
Participant is ≥ 18 years of age, or older if specified by local law
Participant has documented paroxysmal or persistent atrial fibrillation not related to a reversible cause
Participant has AF-related symptoms, and/or presence of CHF or LV dysfunction
Participant has a CHADSVASc>=3 in women and >=2 in men
Participant has had prior AF ablation (including surgical ablation)
Participant has had prior left atrial appendage occlusion or closure
Participant has an intracardiac mass or thrombus
Participant has had a bleeding disorder or inability to tolerate short-term oral anticoagulation
Northwell Health
Lead sponsor
Boston Scientific Corporation
Collaborator