[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541002":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":63,"studyPopulation":19,"armGroups":64,"interventions":73,"overallOfficials":80,"centralContacts":106,"locations":114,"responsibleParty":140,"collaborators":19,"id":142,"slug":19,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":145,"acronym":19,"eligibilityCriteria":146,"healthyVolunteers":143,"sex":147,"minAge":148,"maxAge":19,"enrollmentInfo":149,"targetDuration":19,"studyType":152,"phases":153,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":122,"whyStopped":19,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"fullName":5,"class":6},"Atrial Fibrillation Network","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":19},[9,13],{"measure":10,"description":11,"timeFrame":12},"Composite of cardiovascular complications related to AF","It is defined as time from randomisation to the first occurrence of a composite of cardiovascular death, stroke (either ischemic or hemorrhagic), or hospitalisation for worsening of heart failure.","Throughout study completion, estimated at a mean of 4 years",{"measure":14,"description":15,"timeFrame":12},"The primary safety outcome is a composite of all-cause death and serious complications of AF therapy.","Serious Adverse Events (SAEs), including primary and secondary outcome parameters if based on clinical events, will be adjudicated by the independent Clinical Event Committee (CEC) according to standardised definitions given in the CEC charter.",[17,20,22,24,26,28,30,33,37,39,43,47,49,51],{"measure":18,"description":19,"timeFrame":12},"Number of nights spent in hospital",null,{"measure":21,"description":19,"timeFrame":12},"Time from randomisation to first occurrence of each of the individual components of the primary outcome",{"measure":23,"description":19,"timeFrame":12},"All-cause death",{"measure":25,"description":19,"timeFrame":12},"Serious adverse events related to AF therapy",{"measure":27,"description":19,"timeFrame":12},"Time from randomisation to first cardiovascular hospitalisation",{"measure":29,"description":19,"timeFrame":12},"Number of cardiovascular hospitalisations (over-night stay)",{"measure":31,"description":19,"timeFrame":32},"Changes in left ventricular ejection fraction","comparing baseline with 24 months follow up (FU)",{"measure":34,"description":35,"timeFrame":36},"Changes in quality of life","assessed by EQ-5D-5L","comparing baseline with 12 and 24 months FU",{"measure":34,"description":38,"timeFrame":36},"assessed by AFEQT",{"measure":40,"description":41,"timeFrame":42},"Changes in cognitive function","assessed by Montreal-Cognitive-Assessment-Test","comparing baseline with 24 months FU",{"measure":44,"description":45,"timeFrame":46},"Cardiac rhythm status","sinus rhythm compared to AF","at 12 and 24 months FU",{"measure":48,"description":19,"timeFrame":46},"AF pattern",{"measure":50,"description":19,"timeFrame":12},"Time from randomisation to first clinical recurrence of AF",{"measure":52,"description":53,"timeFrame":12},"Time from randomisation to first progression of AF","i. e. from paroxysmal to persistent or longstanding persistent or permanent and each of these components",{"allocation":55,"interventionModel":56,"interventionModelDescription":19,"primaryPurpose":57,"observationalModel":19,"timePerspective":19,"maskingInfo":58},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":59,"maskingDescription":60,"whoMasked":61},"SINGLE","blinded endpoint assessment",[62],"OUTCOMES_ASSESSOR","Atrial Fibrillation (AF) is associated with high morbidity and mortality. Even on optimal anticoagulation and therapy of concomitant conditions, many patients with AF suffer cardiovascular events, especially heart failure events, stroke, and cardiovascular death. Most of these events occur in elderly patients with comorbidities. Early rhythm control, mainly delivered using antiarrhythmic drugs, reduces AF-related complications when added to anticoagulation, rate control, and treatment of comorbidities when compared to current practice that offers rhythm control mainly to reduce symptoms. The outcome-reducing effect of early rhythm control is most pronounced in patients with multiple comorbidities, quantified by a CHA2DS2-VASc score ≥ 4. Attaining sinus rhythm is the key mediator for the outcome-reducing effect of early rhythm control. Atrial fibrillation ablation controls the rhythm better than drug-based rhythm control, avoids long-term antiarrhythmic drug treatment, thus reducing polypharmacy, and may therefore be the ideal rhythm control treatment in patients with AF and a high comorbidity burden. This hypothesis needs testing. The investigator-initiated EASThigh-AFNET 11 trial evaluates the effectiveness and safety of early atrial fibrillation ablation in patients with recently diagnosed AF and a high comorbidity burden.\n\nEASThigh-AFNET 11 is a Treatment Strategy trial randomizing 2312 patients with AF and a high comorbidity burden to early atrial fibrillation ablation or usual care to achieve a fixed number of primary endpoint events of n=527. All therapies are clinically approved. The primary outcome is a composite of cardiovascular death, stroke, and hospitalization for worsening of heart failure. The primary safety outcome is a composite of all-cause death and serious complications of AF therapy. Secondary outcome parameters address safety, patient reported outcomes and cognitive function.\n\nEASThigh-AFNET 11 was recommended for funding by the Expert Advisory Panel of the Global Cardiovascular Research Funders Forum (GCRFF).",[65,69],{"label":66,"type":6,"description":19,"interventionNames":67},"Early atrial fibrillation ablation",[68],"Other: Early atrial fibrillation ablation",{"label":70,"type":6,"description":19,"interventionNames":71},"Usual Care",[72],"Other: Usual Care",[74,77],{"type":6,"name":66,"description":75,"armGroupLabels":76,"otherNames":19},"Patients randomised to early atrial fibrillation ablation will undergo pulmonary vein isolation within 2 months after randomisation.",[66],{"type":6,"name":70,"description":78,"armGroupLabels":79,"otherNames":19},"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.",[70],[81,85,87,91,94,97,100,103],{"name":82,"affiliation":83,"role":84},"Paulus Kirchhof, Prof. Dr.","University Heart and Vascular Center Hamburg, University Hospital Hamburg Eppendorf","STUDY_DIRECTOR",{"name":86,"affiliation":83,"role":84},"Andreas Rillig, PD Dr.",{"name":88,"affiliation":89,"role":90},"Jason Andrade, Prof. Dr.","University of British Columbia, Vancouver General Hospital, Department of Electrophysiology","PRINCIPAL_INVESTIGATOR",{"name":92,"affiliation":93,"role":90},"André Ng, Prof. Dr.","Department of Cardiovascular Sciences, University of Leicester",{"name":95,"affiliation":96,"role":90},"Prash Sanders, Prof. Dr.","Centre for Heart Rhythm Disorders, University of Adelaide, Royal Adelaide Hospital",{"name":98,"affiliation":99,"role":90},"Volker Straub","Patient representative",{"name":101,"affiliation":102,"role":90},"Kevin Vernooy, Prof. Dr.","Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center (MUMC)",{"name":104,"affiliation":105,"role":90},"Antonia Zapf, Prof. Dr.","Universitätsklinikum Hamburg-Eppendorf",[107,112],{"name":108,"role":109,"phone":110,"phoneExt":19,"email":111},"Antje Albring, Dr.","CONTACT","+49 251 980 1330","easthigh@af-net.eu",{"name":113,"role":109,"phone":110,"phoneExt":19,"email":111},"Anna-Katharina Quade",[115,121,125,128,131,134,137],{"facility":116,"status":117,"city":118,"state":19,"zip":19,"country":119,"countryCode":120,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Several sites","NOT_YET_RECRUITING","Multiple Locations","Australia","AU",{"facility":116,"status":122,"city":118,"state":19,"zip":19,"country":123,"countryCode":124,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"RECRUITING","Canada","CA",{"facility":116,"status":122,"city":118,"state":19,"zip":19,"country":126,"countryCode":127,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Germany","DE",{"facility":116,"status":122,"city":118,"state":19,"zip":19,"country":129,"countryCode":130,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Netherlands","NL",{"facility":116,"status":122,"city":118,"state":19,"zip":19,"country":132,"countryCode":133,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Poland","PL",{"facility":116,"status":122,"city":118,"state":19,"zip":19,"country":135,"countryCode":136,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Spain","ES",{"facility":116,"status":117,"city":118,"state":19,"zip":19,"country":138,"countryCode":139,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"United Kingdom","UK",{"type":141,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","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":150,"type":151},2312,"ESTIMATED","INTERVENTIONAL",[154],"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.",[157],"Atrial Fibrillation",[66,159,160,161,162,163,164,165],"High comorbidity burden","CHA2DS2-VASc score","Early rhythm control","Stroke","Heart failure","Cardiovascular death","Cryoballoon","2026-01-06",{"date":168,"type":169},"2026-01-08","ACTUAL",{"date":171,"type":169},"2024-10-14",{"date":173,"type":151},"2030-05",{"name":5,"class":6},7]