Home › Atrial Fibrillation › NCT07620262
Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation Study
Recruiting
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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.
What is being tested
- Remapping Procedure (device)
Sponsor: Northwell Health · Participants: 50 · Started: May 1, 2026
Contact the study team
Official record on ClinicalTrials.gov — NCT07620262
Locations in the U.S.
| New York | South Shore University Hospital, Bay Shore |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.