[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100380959":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":39,"locations":49,"responsibleParty":97,"collaborators":102,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":101,"enrollmentInfo":114,"targetDuration":101,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":101,"overallStatus":52,"whyStopped":101,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"University of Luebeck","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Group 1","Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alone",[12],"Procedure: Control intervention",{"label":14,"type":15,"description":16,"interventionNames":17},"Group 2","EXPERIMENTAL","Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation",[18],"Procedure: Experimental intervention",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Control intervention","patients treated with balloon-based ablation of AF by PVI",[9],[10],{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":29},"Experimental intervention",[14],[30],"Experimental: Group 2 Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation",[32,36],{"name":33,"affiliation":34,"role":35},"Roland R. Tilz, Prof. Dr.","Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie","STUDY_DIRECTOR",{"name":37,"affiliation":34,"role":38},"Sorin S. Popescu, MD","STUDY_CHAIR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Roland Tilz, Prof. Dr.","CONTACT","+49451500","44672","roland.tilz@uksh.de",{"name":47,"role":42,"phone":43,"phoneExt":44,"email":48},"Charlotte Eitel, Prof. Dr.","charlotte.eitel@uksh.de",[50,70,82],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"University Hospital Eppendorf, Hamburg, Germany","RECRUITING","Hamburg","Free and Hanseatic City of Hamburg","20251","Germany","DE",{"type":59,"coordinates":60},"Point",[61,62],9.99302,53.55073,{"lat":62,"lon":61},[65],{"name":66,"role":42,"phone":67,"phoneExt":68,"email":69},"Andreas Metzner, Prof. Dr.","0049407410","58320","a.metzner@uke.de",{"facility":71,"status":52,"city":53,"state":54,"zip":72,"country":56,"countryCode":57,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"Asklepios Klinik Altona","22763",{"type":59,"coordinates":74},[61,62],{"lat":62,"lon":61},[77],{"name":78,"role":42,"phone":79,"phoneExt":80,"email":81},"Christian H. Heeger, Prof. Dr.","004940181881","1221","c.heeger@asklepios.com",{"facility":83,"status":52,"city":84,"state":85,"zip":86,"country":56,"countryCode":57,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Clinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany","Lübeck","Schleswig-Holstein","23538",{"type":59,"coordinates":88},[89,90],10.68729,53.86893,{"lat":90,"lon":89},[93,96],{"name":41,"role":42,"phone":94,"phoneExt":95,"email":45},"0049451500","44511",{"name":47,"role":42,"phone":94,"phoneExt":95,"email":48},{"type":98,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":101,"oldOrganization":101},"PRINCIPAL_INVESTIGATOR","Roland Richard Tilz, MD","Head of Electrophysiology Department",null,[103],{"name":104,"class":6},"IHF GmbH - Institut für Herzinfarktforschung","100380959","additional-left-atrial-appendage-isolation-during-balloon-ablation-for-persistent-or-long-standing-persistent-atrial-fibrillation-100380959",false,"NCT04240366","Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation","LALA-LAND-AF","Inclusion Criteria:\n\n1. Persistent or long-standing persistent AF (i.e. continuous AF that was\u002Fis sustained \\>7 days or \\>12 months, respectively)\n2. Age ≥18 and ≤80 years\n3. Indication for AF ablation as per current guidelines\n\nExclusion Criteria:\n\n1. Missing informed consent\n2. LAA diameter \\>25mm 10mm distant from circumflex artery assessed by TEE\n3. Paroxysmal atrial ﬁbrillation\n4. Long-standing persistent atrial ﬁbrillation with a continuous AF duration of \\>4 years\n5. Previous pulmonary vein isolation or MAZE surgery\n6. Previous led atrial appendage closure or surgical excision\n7. Left atrial diameter \\>60 mm at baseline\n8. Left atrial thrombus at baseline","ALL","18 Years",{"count":115,"type":116},350,"ESTIMATED","INTERVENTIONAL",[119],"NA","Additional left atrial appendage isolation during balloon ablation for persistent or long-standing persistent atrial ﬁbrillation can reduce atrial ﬁbrillation reoccurrence within 3-12 months compared to balloon-based pulmonary vein isolation only.",[122],"Persistent or Long-standing Persistent Atrial Fibrillation","2024-08-28",{"date":125,"type":126},"2024-08-29","ACTUAL",{"date":128,"type":126},"2019-12-17",{"date":130,"type":116},"2028-08",{"name":5,"class":6},3]