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
Single group
Remapping Procedure
DeviceRemapping procedure with LAAO Implant with or without additional ablation.
To prospectively assess durability of PFA ablation
Durability analysis will include % of patients with any PV reconnection, % of PVs reconnected, and % of patients with recovered conduction in the endocardial posterior wall (if posterior wall isolation performed at the index procedure).
To assess arrhythmia-free survival in patients with confirmed durable PVI (+/-) posterior wall isolation
Patients demonstrating durable PVI (+/- posterior wall isolation) confirmed during remapping procedure will be monitored for arrhythmia recurrence. Arrhythmia recurrence will be evaluated based on 1-week extended Holter monitoring performed at 6 months and 12 months post ablation.
Assess clinical outcomes following strategy of LAAO implant and potential for repeat AF ablation performed as consecutive procedures.
Clinical outcomes following this novel prospective dual-procedure strategy will be analyzed, including assessment of clinical AT/AF recurrence and symptomatic arrhythmia recurrence.
Assess procedure related outcomes following strategy of LAAO implant and potential for repeat AF ablation performed as consecutive procedures.
Procedural related outcomes following this novel prospective dual-procedure strategy will be analyzed, including assessment of ischemic stroke/TIA, bleeding complications, hospitalizations, and death.
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Northwell Health
Lead sponsor
Boston Scientific Corporation
Collaborator
