protocolSection identificationModule nctId: NCT06324188, orgStudyIdInfo id: EASThigh-AFNET 11, briefTitle: Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2030-02, completionDateStruct date: 2030-05, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Atrial Fibrillation Network, class: OTHER, descriptionModule briefSummary: EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial).The 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., conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: blinded endpoint assessment, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 2312, type: ESTIMATED, armsInterventionsModule interventions name: Early atrial fibrillation ablation, interventions name: Usual Care, outcomesModule primaryOutcomes measure: Composite of cardiovascular complications related to AF, primaryOutcomes measure: The primary safety outcome is a composite of all-cause death and serious complications of AF therapy., secondaryOutcomes measure: Number of nights spent in hospital, secondaryOutcomes measure: Time from randomisation to first occurrence of each of the individual components of the primary outcome, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: Serious adverse events related to AF therapy, secondaryOutcomes measure: Time from randomisation to first cardiovascular hospitalisation, secondaryOutcomes measure: Number of cardiovascular hospitalisations (over-night stay), secondaryOutcomes measure: Changes in left ventricular ejection fraction, secondaryOutcomes measure: Changes in quality of life, secondaryOutcomes measure: Changes in quality of life, secondaryOutcomes measure: Changes in cognitive function, secondaryOutcomes measure: Cardiac rhythm status, secondaryOutcomes measure: AF pattern, secondaryOutcomes measure: Time from randomisation to first clinical recurrence of AF, secondaryOutcomes measure: Time from randomisation to first progression of AF, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Several sites, city: Multiple Locations, country: Australia, locations facility: Several sites, city: Multiple Locations, country: Canada, locations facility: Several sites, city: Multiple Locations, country: Germany, locations facility: Several sites, city: Multiple Locations, country: Netherlands, locations facility: Several sites, city: Multiple Locations, country: United Kingdom, hasResults: False