[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655584":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":43,"interventions":60,"overallOfficials":33,"centralContacts":72,"locations":78,"responsibleParty":93,"collaborators":33,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":33,"enrollmentInfo":104,"targetDuration":33,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":118,"whyStopped":33,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Medisch Spectrum Twente","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Number of unplanned cardiac care utilization","Number of unplanned cardiac care utilization. Healthcare utilization will be assessed as the number of healthcare episodes occurring during the study observation period. Each unique healthcare episode will be classified to the principal setting of care (hospitalization, emergency care, daycare\u002Fday case, or outpatient clinic). Healthcare episodes involving transfer from one setting to another will be counted according to the highest level of care reached, to avoid double counting. Unplanned healthcare utilization comprises unscheduled healthcare episodes initiated because of an acute, unexpected, worsening, or urgent health problem. This includes unplanned hospitalizations, emergency-care visits, and unplanned outpatient or urgent-care visits.","18 months",[14,17,20,23,26,28,31],{"measure":15,"description":16,"timeFrame":12},"Number of planned cardiac care utilization","Planned healthcare utilization comprises healthcare episodes scheduled or arranged in advance for routine, preventive, diagnostic, therapeutic, monitoring, rehabilitation, or follow-up care. This includes planned hospitalizations, planned daycare\u002Fday-case encounters, and planned outpatient clinic visits.",{"measure":18,"description":19,"timeFrame":12},"Time to first diagnosis of AF","The clinical diagnosis of AF must be supported by ECG documentation showing a single-lead recording of 30 seconds or a standard 12-lead ECG, captured via the assigned monitoring de-vice or routine clinical care.",{"measure":21,"description":22,"timeFrame":12},"The number of participants diagnosed with AF","AF diagnosis will be based on ECG documentation obtained through the assigned monitoring strategy or routine clinical care",{"measure":24,"description":25,"timeFrame":12},"Pharmaceutical and\u002For CIED implantation management changes","Derived parameters will include the initiation\u002Fdose adjustment of oral anticoagulants (OAC), initiation of new rate\u002Frhythm control medications to treat AF, performance of electrical\u002Fpharmacological cardioversion, or referral for catheter ablation.",{"measure":27,"description":27,"timeFrame":12},"Number of overall arrhythmia diagnosis",{"measure":29,"description":30,"timeFrame":12},"Quality of life Kansas City Cardiomyopathy Questionnaire","The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be collected at baseline and 18 months.",{"measure":32,"description":32,"timeFrame":12},"Mortality",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":40},"DOUBLE",[41,42],"INVESTIGATOR","OUTCOMES_ASSESSOR",[44,50,55],{"label":45,"type":46,"description":47,"interventionNames":48},"Arm 1: Hospital-driven continuous monitoring with an implantable loop recorder","ACTIVE_COMPARATOR","Arm 1: Hospital-driven continuous monitoring with an implantable loop recorder (ILR)",[49],"Device: Implantable loop recorder",{"label":51,"type":46,"description":52,"interventionNames":53},"Arm 2: Patient-driven portable ECG monitoring","Patient-driven portable ECG monitoring",[54],"Device: Patient-driven portable ECG monitoring",{"label":56,"type":46,"description":57,"interventionNames":58},"Arm 3: Usual Care","All patients are treated according to the ESC guidelines (ESC HF 2026).6 The data flow includes peri-odic outpatient utilization.",[59],"Other: Usual Care",[61,66,68],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":33},"DEVICE","Implantable loop recorder","Hospital-driven continuous monitoring with an implantable loop recorder",[45],{"type":62,"name":52,"description":52,"armGroupLabels":67,"otherNames":33},[51],{"type":6,"name":69,"description":70,"armGroupLabels":71,"otherNames":33},"Usual Care","Usual care",[56],[73],{"name":74,"role":75,"phone":76,"phoneExt":33,"email":77},"Dr. Schuuring, MD PhD","CONTACT","0031534872000","mark.schuuring@utwente.nl",[79],{"facility":5,"status":33,"city":80,"state":33,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Enschede","7512 KZ","Netherlands","NL",{"type":85,"coordinates":86},"Point",[87,88],6.89583,52.21833,{"lat":88,"lon":87},[91],{"name":92,"role":75,"phone":76,"phoneExt":33,"email":77},"Dr Schuuring, MD PhD",{"type":94,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100655584","phase-4-alert-hf-early-detection-and-intervention-on-atrial-fibrillation-in-heart-failure-patients-100655584",false,"NCT07816458","Alert-HF: Early Detection and Intervention on Atrial Fibrillation in Heart Failure Patients","Alert-HF","Inclusion Criteria:\n\n* Adult patients with HF and no history of documented AF on electrocardiogram (ECG) are eligible.\n\nExclusion Criteria:\n\n* Patients with CIED such as an implantable cardioverter defibrillator (ICD), Cardiac Resyn-chronization Therapy Defibrillator (CRT-D), or pacemaker.\n* Documented AF before inclusion\n* Admission to hospices or palliative care\n* Inability to communicate in Dutch or English.\n* Participant is under age of 18 years old\n* Participant is pregnant\n* Mental disorders that, according to the treating physician, make participation unsafe","ALL","18 Years",{"count":105,"type":106},258,"ESTIMATED","INTERVENTIONAL",[109],"PHASE4","The goal of this clinical trial is to learn if using heart monitoring devices can lower unplanned hospital visits in adults with heart failure (HF). It focuses on adults with heart failure who have no history of an irregular heartbeat called atrial fibrillation (AF).\n\nThe main questions the trial aims to answer are:\n\nDoes a heart monitor placed under the skin lower unplanned hospital visits? Does a portable home device lower unplanned hospital visits?\n\nResearchers will compare these two groups to a standard care group to see which monitoring approach works best.\n\nParticipants will:\n\nAnswer a health survey at the start of the study and after 18 months. Have a small heart monitor placed under their chest skin to watch their heart rhythm, if they are in the first group.\n\nUse a handheld device to take weekly heart readings at home, if they are in the second group.\n\nFollow standard care from their regular doctor without any extra devices, if they are in the third group.",[112],"Heart Failure",[112,114,115,116,117],"Implantable loop recorder (ILR)","Portable ECG","Atrial fibrillation","Care consumption","NOT_YET_RECRUITING","2026-09-07",{"date":121,"type":122},"2026-09-11","ACTUAL",{"date":124,"type":106},"2027-01",{"date":126,"type":106},"2029-06",{"name":5,"class":6},1]