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

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

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

Conditions2

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