N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Northwell Health • ClinicalTrials.gov ID: NCT07620262

Registry updated: 2026-10-13
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • Remapping Procedure (Device)
    Remapping procedure with LAAO Implant with or without additional ablation.

Eligibility criteria

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

Conditions

Atrial Fibrillation (AF)

Locations

  • South Shore University Hospital — Bay Shore, New York, United States
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record