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

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation (AF)

In brief

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.

Key facts

Study ID

NCT07620262

Run by

Northwell Health

People needed

50

Starts

2026-05-01

Expected to finish

2028-07-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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
• Participant has longstanding persistent AF ongoing for greater than 10 years
• Participant has Left atrial appendage anatomy unsuitable for LAAO device
• Participant has an LA diameter >6 cm

Where it is running

• South Shore University Hospital — Bay Shore, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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