[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617587":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":57,"studyPopulation":53,"armGroups":58,"interventions":65,"overallOfficials":70,"centralContacts":75,"locations":84,"responsibleParty":170,"collaborators":53,"id":173,"slug":53,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":174,"sex":180,"minAge":181,"maxAge":53,"enrollmentInfo":182,"targetDuration":53,"studyType":185,"phases":186,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":87,"whyStopped":53,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},{"fullName":5,"class":6},"German Heart Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Rate of acute AF termination","Acute AF termination (to sinus rhythm or conversion into an organized atrial tachycardia) upon ablation","Procedural",[14,18,21,24,27],{"measure":15,"description":16,"timeFrame":17},"Proportion of patients with arrhythmia-free survival","Absence of any atrial tachyarrhythmia (atrial fibrillation \\[AF\\], atrial flutter \\[AFL\\] or atrial tachycardia \\[AT\\]) between days 91 and 365 post ablation. AF, AFL or AT will qualify as a recurrence after ablation if it lasts 30 s or longer.","Days 91 to 365 post-ablation",{"measure":19,"description":20,"timeFrame":17},"Proportion of patients with AF-free survival","Absence of atrial fibrillation \\[AF\\] between days 91 and 365 post ablation. AF will qualify as a recurrence after ablation if it lasts 30 s or longer.",{"measure":22,"description":23,"timeFrame":17},"Time to arrhythmia recurrence","Time to first atrial tachyarrhythmia (atrial fibrillation \\[AF\\], atrial flutter \\[AFL\\] or atrial tachycardia \\[AT\\]) between days 91 and 365 post ablation. AF, AFL or AT will qualify as a recurrence after ablation if it lasts 30 s or longer.",{"measure":25,"description":26,"timeFrame":17},"Time to AF recurrence","Time to first atrial fibrillation \\[AF\\] between days 91 and 365 post ablation. AF will qualify as a recurrence after ablation if it lasts 30 s or longer.",{"measure":28,"description":29,"timeFrame":30},"Rate of procedure-related complications","Composite safety endpoint composed of:\n\n* cardiac tamponade requiring drainage\n* persistent phrenic nerve palsy lasting \\>24 hours\n* serious vascular complications requiring intervention\n* stroke\u002FTIA\n* atrioesophageal fistula\n* death","Day 0 to 30 post-ablation",[32,36,39,41,44,46,48],{"measure":33,"description":34,"timeFrame":35},"Procedure time","Skin-to-skin duration of the ablation (procedural endpoint)","Day 0",{"measure":37,"description":38,"timeFrame":35},"Total left atrium indwelling time","Procedural endpoint",{"measure":40,"description":38,"timeFrame":35},"Fluoroscopy time",{"measure":42,"description":38,"timeFrame":43},"Hemolysis marker levels on day 1 post-ablation","Day 1 post-ablation",{"measure":45,"description":38,"timeFrame":43},"GFR on day 1 post-ablation",{"measure":47,"description":38,"timeFrame":30},"Proportion of patients with acute renal failure",{"measure":49,"description":38,"timeFrame":43},"hsTroponin on day 1 post-ablation",{"allocation":51,"interventionModel":52,"interventionModelDescription":53,"primaryPurpose":54,"observationalModel":53,"timePerspective":53,"maskingInfo":55},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":56,"maskingDescription":53,"whoMasked":53},"NONE","The aim of this study is to test the feasibility and potential of a personalized, non-invasive mapping-guided ablation approach in patients with persistent atrial fibrillation (AF), who are unlikely to benefit from empirical pulmonary vein isolation alone. As a pilot study, it is designed to assess feasibility and procedural efficacy as well as potential signals of harm.\n\nGeneral Strategy:\n\nPatients with persistent AF planned for catheter ablation are eligible in case of left atrial enlargement.\n\nThe study intervention consists of two steps:\n\n1. Empirical pulmonary vein isolation in all patients (current standard of care).\n2. A personalized ablation approach targeting up to three additional atrial regions which harbour critical AF-perpetuating sources:\n\n   * Target regions are selected based on the temporal Stability of local Atrial High-Rate Activity (SAHRA) using a non-invasive global mapping system (Acorys, Corify Care).\n   * Selected target regions displaying stable high-rate activity are isolated or homogenized according to predefined regional borders based on the 15-segment bi-atrial model of the EHRA and EACVI Clinical Consensus on Standardized Atrial Regionalization.",[59],{"label":60,"type":61,"description":62,"interventionNames":63},"Non-invasive mapping-guided ablation","EXPERIMENTAL","In this arm patients undergo a personalized ablation approach: In addition to conventional pulmonary vein isolation, additional target regions will be ablated based on non-invasive global mapping.",[64],"Procedure: Non-invasive mapping-guided ablation",[66],{"type":67,"name":60,"description":68,"armGroupLabels":69,"otherNames":53},"PROCEDURE","The study intervention consists of\n\n1. Empirical pulmonary vein isolation (current standard of care) plus\n2. A personalized ablation approach targeting up to three additional atrial regions which harbour critical AF-perpetuating sources:\n\n   * Target regions are selected based on the temporal Stability of local Atrial High-Rate Activity (SAHRA) using a non-invasive global mapping system (Acorys, Corify Care). Local high-rate activity is confirmed by endocardial mapping.\n   * Selected target regions displaying stable high-rate activity are isolated or homogenized according to predefined regional borders based on the 15-segment bi-atrial model of the EHRA and EACVI Clinical Consensus on Standardized Atrial Regionalization (Althoff et al. 2025).",[60],[71],{"name":72,"affiliation":73,"role":74},"Till F Althoff, M.D.","German Heart Center of the Charitè, Berlin, Department of Cardiology, Angiology and Intensive Care Medicine","PRINCIPAL_INVESTIGATOR",[76,80],{"name":72,"role":77,"phone":78,"phoneExt":53,"email":79},"CONTACT","0049 30 450613163","till.althoff@dhzc-charite.de",{"name":81,"role":77,"phone":82,"phoneExt":53,"email":83},"Gerhard Hindricks, M.D.","030450613163","gerhard.hindricks@dhzc-charite.de",[85,102,120,137,155],{"facility":86,"status":87,"city":88,"state":53,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"German Heart Center of the Charité, Charité University Hospital Berlin","RECRUITING","Berlin","10117","Germany","DE",{"type":93,"coordinates":94},"Point",[95,96],13.41053,52.52437,{"lat":96,"lon":95},[99,100,101],{"name":72,"role":77,"phone":78,"phoneExt":53,"email":79},{"name":53,"role":77,"phone":53,"phoneExt":53,"email":79},{"name":72,"role":74,"phone":53,"phoneExt":53,"email":53},{"facility":103,"status":104,"city":105,"state":53,"zip":106,"country":90,"countryCode":91,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Frankfurt University Heart and Vascular Center","NOT_YET_RECRUITING","Frankfurt am Main","60598",{"type":93,"coordinates":108},[109,110],8.68417,50.11552,{"lat":110,"lon":109},[113,117,119],{"name":114,"role":77,"phone":115,"phoneExt":53,"email":116},"Reza Wakili, M.D.","0049 69 63017404","reza.wakili@herz-frankfurt.de",{"name":53,"role":77,"phone":53,"phoneExt":53,"email":118},"Reza.Wakili@unimedizin-ffm.de",{"name":114,"role":74,"phone":53,"phoneExt":53,"email":53},{"facility":121,"status":104,"city":122,"state":53,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Central Lisbon University Hospital Centre (CHULC), Hospital de Santa Marta","Lisbon","1169-024","Portugal","PT",{"type":93,"coordinates":127},[128,129],-9.1498,38.72509,{"lat":129,"lon":128},[132,136],{"name":133,"role":77,"phone":134,"phoneExt":53,"email":135},"Mario Martins Oliveira, M.D.","0035 121 3594000","m.martinsoliveira@gmail.com",{"name":133,"role":74,"phone":53,"phoneExt":53,"email":53},{"facility":138,"status":104,"city":139,"state":53,"zip":140,"country":141,"countryCode":142,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Hospital Clinic, University of Barcelona","Barcelona","08036","Spain","ES",{"type":93,"coordinates":144},[145,146],2.15899,41.38879,{"lat":146,"lon":145},[149,153],{"name":150,"role":77,"phone":151,"phoneExt":53,"email":152},"Ivo Roca-Luque, M.D. Ph.D.","0034 93 2271778","iroca@clinic.cat",{"name":154,"role":74,"phone":53,"phoneExt":53,"email":53},"Ivo Roca-Luque, M.D.",{"facility":156,"status":104,"city":157,"state":53,"zip":158,"country":141,"countryCode":142,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Gregorio Marañón General University Hospital","Madrid","28007",{"type":93,"coordinates":160},[161,162],-3.70256,40.4165,{"lat":162,"lon":161},[165,169],{"name":166,"role":77,"phone":167,"phoneExt":53,"email":168},"Felipe Atienza, M.D.","0034 915 86 80 00","felipe.atienza@salud.madrid.org",{"name":166,"role":74,"phone":53,"phoneExt":53,"email":53},{"type":74,"investigatorFullName":171,"investigatorTitle":172,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"Till Althoff","Head of Research and Principal Investigator","100617587",false,"NCT07320560","Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping","Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping - the CURE-AF Pilot Study","CURE-AF","Inclusion Criteria:\n\nAblation-naïve patients with:\n\n1. Persistent AF planned for catheter ablation plus\n2. Left atrial enlargement (LA diameter ≥45 mm or LA volume index ≥35ml\u002Fm2 or LA area ≥20 cm2)\n\nExclusion Criteria:\n\n* Previous cardiac ablation\n* Age \\\u003C18 years\n* Pregnancy or lactation\n* Previous stroke\u002FTIA\n* Severe left ventricular dysfunction (LVEF \\\u003C35%)\n* Renal failure (GFR \\\u003C30 ml\u002Fmin)\n* Dermal disease or hypersensitivity predisposing for skin irritation or exanthema","ALL","18 Years",{"count":183,"type":184},45,"ESTIMATED","INTERVENTIONAL",[51],"This pilot study investigates if non-invasive global mapping can guide catheter ablation of atrial fibrillation (AF) by defining personalized targets based on the temporal Stability of local Atrial High-Rate Activity (SAHRA). The study also assesses efficacy and safety of this approach and evaluates potential signals of harm. The main questions it aims to answer are:\n\n* Does ablation of targets defined by non-invasive global mapping improve rates of acute atrial fibrillation termination?\n* Does such a personalized ablation approach reduce arrhythmia recurrence rates? Researchers will compare the results of the personalized ablation approach with comparable patients that had undergone a conventional \"empirical\" ablation approach (pulmonary vein isolation).\n\nParticipants will:\n\n* Undergo a personalized catheter ablation approach employing both a non-invasive global mapping system and a conventional intracardiac mapping system\n* Visit the clinic 3, 6 and 12 months after ablation for clinical follow-up\n* Schedule a telephone visit 9 and 24 months after ablation for clinical follow-up",[189],"Atrial Fibrillation (AF)",[191,192,193,194,195,196,197],"Atrial Fibrillation","Catheter Ablation","Non-invasive mapping","Global Mapping","Electrocardiographic Imaging","Body Surface Mapping","Atrial fibrillation drivers","2025-12-25",{"date":200,"type":201},"2026-01-06","ACTUAL",{"date":203,"type":184},"2026-01-15",{"date":205,"type":184},"2027-12-31",{"name":5,"class":6},5]