[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579500":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":50,"responsibleParty":214,"collaborators":10,"id":216,"slug":217,"hasResults":218,"nctId":219,"briefTitle":220,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":218,"sex":223,"minAge":224,"maxAge":10,"enrollmentInfo":225,"targetDuration":10,"studyType":228,"phases":10,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":93,"whyStopped":10,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":247},{"fullName":5,"class":6},"Volta Medical","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Tailored",null,"Patients from the \"Tailored\" group in the initial study TAILORED-AF. Patients in this group underwent \"Tailored\" AF ablation, i.e. the analysis and targeting of pathological areas using Volta Medical's artificial intelligence software (Volta AF-Xplorer, formerly VX1), in addition to electrical isolation of the pulmonary veins (PVI).",[13,14],"Device: Volta AF-Xplorer","Procedure: Dispersion ablation + PVI",{"label":16,"type":10,"description":17,"interventionNames":18},"Active Comparator: Anatomical","Patients from the \"Anatomical\" group in the initial study TAILORED-AF. Patients in this group underwent PVI only.",[19],"Procedure: PVI",[21,26,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"DEVICE","Volta AF-Xplorer","Dispersion ablation strategy guided by Volta Medical AI-software targeting areas of spatiotemporal dispersed electrograms",[9],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"PROCEDURE","Dispersion ablation + PVI","TAILORED-AF index procedure: Dispersion ablation + PVI",[9],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"PVI","TAILORED-AF index procedure: PVI only",[16],[36],{"name":37,"affiliation":38,"role":39},"Isabel DEISENHOFER, MD","Deutsches Herzzentrum Muenchen","PRINCIPAL_INVESTIGATOR",[41,47],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Paola MILPIED","CONTACT","(0)768025499","0033","paola.milpied@volta-medical.com",{"name":48,"role":43,"phone":10,"phoneExt":10,"email":49},"Cecile 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Nord","Saint-Denis","93207",{"type":59,"coordinates":145},[146,147],2.35387,48.93564,{"lat":147,"lon":146},[150],{"name":151,"role":43,"phone":10,"phoneExt":10,"email":10},"Antoine Lepillier, MD",{"facility":153,"status":53,"city":154,"state":10,"zip":155,"country":56,"countryCode":57,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Clinique Rhéna","Strasbourg","67000",{"type":59,"coordinates":157},[158,159],7.74553,48.58392,{"lat":159,"lon":158},[162],{"name":163,"role":43,"phone":10,"phoneExt":10,"email":10},"Babé Bakouboula, MD",{"facility":165,"status":53,"city":166,"state":10,"zip":167,"country":56,"countryCode":57,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Clinique Pasteur","Toulouse","31076",{"type":59,"coordinates":169},[170,171],1.44367,43.60426,{"lat":171,"lon":170},[174],{"name":175,"role":43,"phone":10,"phoneExt":10,"email":10},"Jean-Paul Albenque, MD",{"facility":177,"status":53,"city":178,"state":10,"zip":179,"country":56,"countryCode":57,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"CHRU Nancy, Institut Lorrain du coeur et des vaisseaux","Vandœuvre-lès-Nancy","54500",{"type":59,"coordinates":181},[182,183],6.17114,48.66115,{"lat":183,"lon":182},[186],{"name":187,"role":43,"phone":10,"phoneExt":10,"email":10},"Christian De Chillou, MD",{"facility":189,"status":53,"city":190,"state":10,"zip":191,"country":192,"countryCode":193,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Klinikum Coburg","Coburg","96450","Germany","DE",{"type":59,"coordinates":195},[196,197],10.96384,50.25937,{"lat":197,"lon":196},[200],{"name":201,"role":43,"phone":10,"phoneExt":10,"email":10},"Mathias Forkmann, MD",{"facility":203,"status":53,"city":204,"state":10,"zip":205,"country":192,"countryCode":193,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"German Heart Center","Munich","80636",{"type":59,"coordinates":207},[208,209],11.57549,48.13743,{"lat":209,"lon":208},[212],{"name":213,"role":43,"phone":10,"phoneExt":10,"email":10},"Isabel Deisenhofer, MD",{"type":215,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100579500","long-term-evaluation-of-tailored-vs-anatomical-ablation-strategy-for-persistent-atrial-fibrillation-100579500",false,"NCT06825104","Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation","TAILORED-LT","Inclusion Criteria:\n\n* Patient who participated in the Tailored AF study\n* Patient not withdrawn during the 12-month follow-up period post-index procedure in the Tailored AF study\n* Patient able and willing to provide written informed consent to participate in this extension Tailored-LT study\n\nExclusion Criteria:\n\n* Person deprived of liberty or under guardianship\n* Person unable to undergo a medical monitoring for geographical, social or psychological reasons","ALL","18 Years",{"count":226,"type":227},278,"ESTIMATED","OBSERVATIONAL","The TAILORED-LT study is conducted as an extension follow-up until 5 years of the initial TAILORED-AF study (NCT04702451), in order to demonstrate the long-term superiority in terms of freedom of atrial fibrillation (AF) of a tailored ablation strategy targeting areas of spatio-temporal dispersed electrograms in combination with pulmonary veins isolation (PVI) over an anatomical ablation strategy targeting PVI alone for the initial ablation procedure of persistent AF.",[231],"Atrial Fibrillation",[233,234,23,235,236,5,237],"Artificial Intelligence","VX1","Medical Device","Cardiac Dispersion","Software","2025-03-10",{"date":240,"type":241},"2025-03-13","ACTUAL",{"date":243,"type":241},"2025-03-06",{"date":245,"type":227},"2027-12-31",{"name":5,"class":6},13]