RecruitingNot ApplicableNCT07620262

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

Sponsor

Northwell Health

Enrollment

50 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)

Summary

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

Min Age: 18 Years

Inclusion Criteria7

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
There is appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation for thromboembolic protection
Participant is willing and capable of providing informed consent
Participant is willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center

Exclusion Criteria11

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
Participant has a life expectancy < 1 year
Participant has had recent MI, CVA, or cardiac surgery in preceding 90 days
Participant has an inability to comply with outpatient follow-up, or cognitive impairment that precludes understanding of procedure risks and benefits Participant has an active systemic infection
Participant has a mechanical heart valve through which the catheter must pass, or severe mitral stenosis
Participant has a vena cava embolic protection filter devices and/or known femoral thrombus who require catheter insertion from the femoral approach
Participant had congenital heart disease where the underlying abnormality increases the risk of ablation (e.g. severe rotational anomalies of the heart or great vessels)
Participant is woman of childbearing potential who is pregnant, lactating, not using a reliable form of contraception, or who is planning to become pregnant during the anticipated study period