Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwell Health

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Remapping Procedure

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Northwell Health

Lead sponsor

Boston Scientific Corporation

Collaborator