[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640712":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":41,"collaborators":43,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":19,"enrollmentInfo":56,"targetDuration":19,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":23,"whyStopped":19,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Northwell Health","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-arm, open label - all enrolled subjects","EXPERIMENTAL","Remapping procedure with LAAO Implant with or without additional ablation.",[13],"Device: Remapping Procedure",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DEVICE","Remapping Procedure",[9],null,[21],{"facility":22,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"South Shore University Hospital","RECRUITING","Bay Shore","New York","11706","United States","US",{"type":30,"coordinates":31},"Point",[32,33],-73.24539,40.7251,{"lat":33,"lon":32},[36],{"name":37,"role":38,"phone":39,"phoneExt":19,"email":40},"Rachel Gentles","CONTACT","631-968-3016","rgentles1@northwell.edu",{"type":42,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[44],{"name":45,"class":46},"Boston Scientific Corporation","INDUSTRY","100640712","prospective-remapping-with-concomitant-left-atrial-appendage-occlusion-to-ensure-durable-electroporation-study-100640712",false,"NCT07620262","Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation Study","PRECLUDE","Inclusion Criteria:\n\n* Participant is ≥ 18 years of age, or older if specified by local law\n* Participant has documented paroxysmal or persistent atrial fibrillation not related to a reversible cause\n* Participant has AF-related symptoms, and\u002For presence of CHF or LV dysfunction\n* Participant has a CHADSVASc\\>=3\n* There is appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation for thromboembolic protection\n* Participant is willing and capable of providing informed consent\n* Participant is willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center\n\nExclusion Criteria:\n\n* Participant has had prior AF ablation (including surgical ablation)\n* Participant has had prior left atrial appendage occlusion or closure\n* Participant has an intracardiac mass or thrombus\n* Participant has had a bleeding disorder or inability to tolerate short-term oral anticoagulation\n* Participant has a life expectancy \\\u003C 1 year\n* Participant has had recent MI, CVA, or cardiac surgery in preceding 90 days\n* 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\n* Participant has a mechanical heart valve through which the catheter must pass, or severe mitral stenosis\n* Participant has a vena cava embolic protection filter devices and\u002For known femoral thrombus who require catheter insertion from the femoral approach\n* 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)\n* 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","ALL","18 Years",{"count":57,"type":58},50,"ESTIMATED","INTERVENTIONAL",[61],"NA","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.",[64],"Atrial Fibrillation (AF)",[66,67,68,69],"Ablation","Atrial Fibrilation","Re-mapping","LAAO Device","2026-05-27",{"date":72,"type":73},"2026-06-02","ACTUAL",{"date":75,"type":73},"2026-05-01",{"date":77,"type":58},"2028-07",{"name":5,"class":6},1]