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Study on Pulsed Field Ablation for Atrial Fibrillation with LAA Occlusion

This study is looking at how well a treatment called pulsed field ablation (PFA) works over time for people with atrial fibrillation (AF). AF is a heart condition where your heart beats too fast or irregularly. PFA uses electrical pulses to create scars in your heart tissue, which helps restore a normal heart rhythm. In this study, you would first have a PFA procedure. Later, you would have a second procedure to check how well the PFA worked and to implant a left atrial appendage occlusion (LAAO) device, which can help prevent strokes. The study wants to see how long the PFA treatment lasts. You might be able to join if you are 18 or older, have documented AF, and have AF-related symptoms or certain heart conditions. The study is currently unclear on its recruitment status and plans to enroll 50 participants.

Study design
This is a single-arm study, meaning all participants receive the same intervention. It is an open-label study, so both you and your doctors will know what treatments you are receiving. The study plans to enroll 50 participants.
What's involved
You would undergo an initial pulsed field ablation procedure. Approximately 30-180 days later, you would have a remapping procedure with a concomitant LAAO implant, which may include additional ablation if needed.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint assesses durability from the initial ablation to the re-mapping procedure, which occurs approximately 30-180 days later.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07620262

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

Recruiting
NAAges 18+InterventionalTreatment
Northwell Health
~50 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:Remapping Procedure

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To prospectively assess durability of PFA ablation
Measured over From Index Ablation to Subsequent Re-mapping procedure with concomitant LAAO implant. The remapping procedure will occur approximately 30-180 days after the index ablation.

Conditions

Atrial Fibrillation (AF)

Explore related trials

Atrial Fibrillation

NCT07620262

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • South Shore University Hospital

    Bay Shore, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Rachel Gentles
[email protected]
631-968-3016
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • To prospectively assess durability of PFA ablationFrom Index Ablation to Subsequent Re-mapping procedure with concomitant LAAO implant. The remapping procedure will occur approximately 30-180 days after the index 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).