Rechecking a Heart Ablation for Atrial Fibrillation During a Later Appendage Closure Procedure
Checks how well a prior ablation held up in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation Study
Key facts
- Where
- Bay Shore, United StatesSee the site
Where in United States
- South Shore University HospitalBay Shore, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Northwell Health
- Trial code
- NCT07620262
- Record updated
- 13 October 2026
- Original 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.Read full original descriptionShow less
Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation 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.
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 had a bleeding disorder or inability to tolerate short-term oral anticoagulation; 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 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 has an intracardiac mass or thrombus; Participant has a life expectancy < 1 year; Participant has a vena cava embolic protection filter devices and/or known femoral thrombus who require catheter insertion from the femoral approach; 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.