[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541002":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":24,"centralContacts":50,"locations":58,"responsibleParty":84,"collaborators":10,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":10,"eligibilityCriteria":91,"healthyVolunteers":88,"sex":92,"minAge":93,"maxAge":10,"enrollmentInfo":94,"targetDuration":10,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":66,"whyStopped":10,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Atrial Fibrillation Network","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Early atrial fibrillation ablation",null,[12],"Other: Early atrial fibrillation ablation",{"label":14,"type":6,"description":10,"interventionNames":15},"Usual Care",[16],"Other: Usual Care",[18,21],{"type":6,"name":9,"description":19,"armGroupLabels":20,"otherNames":10},"Patients randomised to early atrial fibrillation ablation will undergo pulmonary vein isolation within 2 months after randomisation.",[9],{"type":6,"name":14,"description":22,"armGroupLabels":23,"otherNames":10},"Usual care will consist of optimal AF therapy based on guideline recommendations and local protocols and usage.The choice of therapies and medications follows routine care in line with medical guidelines and local policies at the discretion of the treating physician and should be based on the individual medical status of each study patient.",[14],[25,29,31,35,38,41,44,47],{"name":26,"affiliation":27,"role":28},"Paulus Kirchhof, Prof. Dr.","University Heart and Vascular Center Hamburg, University Hospital Hamburg Eppendorf","STUDY_DIRECTOR",{"name":30,"affiliation":27,"role":28},"Andreas Rillig, PD Dr.",{"name":32,"affiliation":33,"role":34},"Jason Andrade, Prof. Dr.","University of British Columbia, Vancouver General Hospital, Department of Electrophysiology","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"André Ng, Prof. Dr.","Department of Cardiovascular Sciences, University of Leicester",{"name":39,"affiliation":40,"role":34},"Prash Sanders, Prof. Dr.","Centre for Heart Rhythm Disorders, University of Adelaide, Royal Adelaide Hospital",{"name":42,"affiliation":43,"role":34},"Volker Straub","Patient representative",{"name":45,"affiliation":46,"role":34},"Kevin Vernooy, Prof. Dr.","Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center (MUMC)",{"name":48,"affiliation":49,"role":34},"Antonia Zapf, Prof. Dr.","Universitätsklinikum Hamburg-Eppendorf",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":10,"email":55},"Antje Albring, Dr.","CONTACT","+49 251 980 1330","easthigh@af-net.eu",{"name":57,"role":53,"phone":54,"phoneExt":10,"email":55},"Anna-Katharina Quade",[59,65,69,72,75,78,81],{"facility":60,"status":61,"city":62,"state":10,"zip":10,"country":63,"countryCode":64,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Several sites","NOT_YET_RECRUITING","Multiple Locations","Australia","AU",{"facility":60,"status":66,"city":62,"state":10,"zip":10,"country":67,"countryCode":68,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"RECRUITING","Canada","CA",{"facility":60,"status":66,"city":62,"state":10,"zip":10,"country":70,"countryCode":71,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Germany","DE",{"facility":60,"status":66,"city":62,"state":10,"zip":10,"country":73,"countryCode":74,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Netherlands","NL",{"facility":60,"status":66,"city":62,"state":10,"zip":10,"country":76,"countryCode":77,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Poland","PL",{"facility":60,"status":66,"city":62,"state":10,"zip":10,"country":79,"countryCode":80,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Spain","ES",{"facility":60,"status":61,"city":62,"state":10,"zip":10,"country":82,"countryCode":83,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"United Kingdom","UK",{"type":85,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100541002","early-atrial-fibrillation-ablation-for-stroke-prevention-in-patients-with-high-comorbidity-burden-easthigh-afnet-11-100541002",false,"NCT06324188","Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)","Inclusion Criteria:\n\nI1. AF first diagnosed within 5 years prior to enrolment and documented in body surface ECG\n\nI2. High comorbidity estimated by CHA2DS2-VASc score of 4 or more\n\nI3. Patient suitable for ablation using cryoballoon ablation systems or other ablation systems with comparable efficacy and safety from Medtronic\n\nI4. Age ≥ 18 years\n\nI5. Provision of signed informed consent\n\nExclusion Criteria:\n\nGeneral exclusion criteria\n\nE1. Any disease that limits life expectancy to less than 1 year.\n\nE2. Participation in another clinical trial, either within the 3 months prior to enrolment or still on-going (participation in potential sub-studies connected to this trial is permitted).\n\nE3. Previous participation in EASThigh-AFNET 11.\n\nE4. Pregnant women.\n\nE5. Breastfeeding women.\n\nE6. Drug abuse or clinically manifest alcohol abuse.\n\nExclusion criteria related to a cardiac condition\n\nE7. Prior AF ablation or surgical therapy of AF.\n\nE8. Patients not suitable for AF ablation.\n\nE9. Patients with a history of stroke which occurred within 3 months prior to enrolment.\n\nE10. Valve disease requiring specific therapy.\n\nExclusion criteria based on laboratory abnormalities\n\nE11. Clinically manifested thyroid dysfunction requiring therapy.","ALL","18 Years",{"count":95,"type":96},2312,"ESTIMATED","INTERVENTIONAL",[99],"NA","EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial).\n\nThe objective of EASThigh-AFNET 11 is to investigate whether early atrial fibrillation ablation in patients with atrial fibrillation (AF) and a high comorbidity burden (CHA2DS2-VASc ≥4) reduces cardiovascular events (stroke, cardiovascular death, or heart failure events) compared to usual care.",[102],"Atrial Fibrillation",[9,104,105,106,107,108,109,110],"High comorbidity burden","CHA2DS2-VASc score","Early rhythm control","Stroke","Heart failure","Cardiovascular death","Cryoballoon","2026-01-06",{"date":113,"type":114},"2026-01-08","ACTUAL",{"date":116,"type":114},"2024-10-14",{"date":118,"type":96},"2030-05",{"name":5,"class":6},7]