Remapping Before/During LAAO: Testing Durable Pulsed Field Ablation for Atrial Fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label study to assess the durability of pulsed field ablation when performed in conjunction with a subsequent left atrial appendage occlusion procedure, at least 30 days apart. The initial ablation will be reassessed with electroanatomic mapping and intracardiac echocardiography, with additional ablation if needed. The study uses standard-of-care practices for ablation and LAAO as part of the protocol, and focuses on technical success of the index procedure rather than long-term rhythm outcomes. Eligible participants are adults with paroxysmal or persistent atrial fibrillation and certain cardiovascular risk factors, who are not candidates for long-term anticoagulation or wish to avoid it. Exclusion criteria include prior AF ablation or prior LAAO, intracardiac masses, thrombus, or bleeding disorders that would preclude short-term anticoagulation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• South Shore University Hospital
  Bay Shore, New York, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.