[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609357":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":43,"locations":51,"responsibleParty":258,"collaborators":260,"id":295,"slug":296,"hasResults":297,"nctId":298,"briefTitle":299,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":297,"sex":302,"minAge":303,"maxAge":10,"enrollmentInfo":304,"targetDuration":10,"studyType":307,"phases":10,"briefSummary":308,"conditions":309,"keywords":313,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":328},{"fullName":5,"class":6},"Montreal Heart Institute","OTHER",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"TAVI",null,"All patients who have had TAVI with a third generation transcatheter heart valve (THV). Medical imaging data (CT, TEE) and preoperative clinical data will be collected for analysis.",[13],"Diagnostic Test: Medical imaging analysis via artificial intelligence algorithms",{"label":15,"type":10,"description":16,"interventionNames":17},"TMVI","Patients who have had a TMVI with a dedicated transeptal device and screen failures. Medical imaging data (CT, TEE) and preoperative clinical data will be collected for analysis.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"TTVI","Patients who have had a TTVI with a dedicated device and screen failures. Medical imaging data (CT, TEE) and preoperative clinical data will be collected for analysis.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"M-TEER","All patients who have had a M-TEER with 1) G4 or newer iteration of MitraClip or 2) G2 or newer iteration of Pascal. Medical imaging data (CT, TEE) and preoperative clinical data will be collected for analysis.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"T-TEER","All patients who have had a T-TEER with G4 or newer iteration of TriClip or 2) G2 or newer iteration of Pascal. Medical imaging data (CT, TEE) and preoperative clinical data will be collected for analysis.",[13],[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"DIAGNOSTIC_TEST","Medical imaging analysis via artificial intelligence algorithms","Development of AI algorithms based on pre-procedural imaging annotations and clinical informations to predict the transcatheter procedural outcomes",[23,27,9,15,19],[37,41],{"name":38,"affiliation":39,"role":40},"Thomas Modine, MD, PhD","University Hospital Bordeaux, France","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":5,"role":40},"Walid Ben Ali, MD, PhD",[44,48],{"name":38,"role":45,"phone":46,"phoneExt":10,"email":47},"CONTACT","+33(0)5 25 377541","thomasmodine@gmail.com",{"name":42,"role":45,"phone":49,"phoneExt":10,"email":50},"+1 5145611037","dr.walidbenali@gmail.com",[52,70,85,98,111,127,140,153,166,176,189,202,217,230,245],{"facility":53,"status":54,"city":55,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Montefiore Medical Center New York","RECRUITING","New York","10467","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-74.00597,40.71427,{"lat":63,"lon":62},[66],{"name":67,"role":45,"phone":68,"phoneExt":10,"email":69},"Andrea Scotti, MD, PhD","+1 718-920-4321","a.scotti@hotmail.com",{"facility":71,"status":54,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Montreal Heart Institute, 5000 Rue Bélanger, Montréal","Montreal","Quebec","H1T 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62","augustincoisne@hotmail.com",{"facility":141,"status":54,"city":142,"state":10,"zip":10,"country":115,"countryCode":116,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"CHU Marseille","Marseille",{"type":60,"coordinates":144},[145,146],5.38107,43.29695,{"lat":146,"lon":145},[149],{"name":150,"role":45,"phone":151,"phoneExt":10,"email":152},"Thomas Cuisset, MD, PhD","+33 04 91 38 59 75","thomas.cuisset@ap-hm.fr",{"facility":154,"status":54,"city":155,"state":10,"zip":10,"country":115,"countryCode":116,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Centre Cardiologique du Nord Paris","Paris",{"type":60,"coordinates":157},[158,159],2.3488,48.85341,{"lat":159,"lon":158},[162],{"name":163,"role":45,"phone":164,"phoneExt":10,"email":165},"Julien Dreyfus, MD, PhD","+33 1 49 33 41 41","dreyfusjulien@yahoo.fr",{"facility":167,"status":54,"city":155,"state":10,"zip":10,"country":115,"countryCode":116,"cosmosGeoPoint":168,"geoPoint":170,"contacts":171},"Institut Cardiovasculaire Paris-Sud Paris",{"type":60,"coordinates":169},[158,159],{"lat":159,"lon":158},[172],{"name":173,"role":45,"phone":174,"phoneExt":10,"email":175},"Myriam Akodad, MD","+33 1 60 13 46 02","akodadmyriam@gmail.com",{"facility":177,"status":54,"city":178,"state":10,"zip":10,"country":115,"countryCode":116,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Centre Hospitalier Universitaire Rennes","Rennes",{"type":60,"coordinates":180},[181,182],-1.67431,48.11109,{"lat":182,"lon":181},[185],{"name":186,"role":45,"phone":187,"phoneExt":10,"email":188},"Erwan Donal, MD, PhD","+33 (0)2 99 28 71 58","erwan.donal@chu-rennes.fr",{"facility":190,"status":54,"city":191,"state":10,"zip":10,"country":115,"countryCode":116,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Clinque Pasteur Toulouse - France","Toulouse",{"type":60,"coordinates":193},[194,195],1.44367,43.60426,{"lat":195,"lon":194},[198],{"name":199,"role":45,"phone":200,"phoneExt":10,"email":201},"Didier Tchétché, MD","+33 5 62 21 31 31","d.tchetche@clinique-pasteur.com",{"facility":203,"status":54,"city":204,"state":10,"zip":10,"country":205,"countryCode":206,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"University Medical Center Hamburg-Eppendorf","Hamburg","Germany","DE",{"type":60,"coordinates":208},[209,210],9.99302,53.55073,{"lat":210,"lon":209},[213],{"name":214,"role":45,"phone":215,"phoneExt":10,"email":216},"Lenard Conradi, MD, PhD","+49 (0) 40 7410 - 58949","l.conradi@uke.de",{"facility":218,"status":54,"city":219,"state":10,"zip":10,"country":205,"countryCode":206,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"Heart Valve Center Mainz","Mainz",{"type":60,"coordinates":221},[222,223],8.28008,49.98185,{"lat":223,"lon":222},[226],{"name":227,"role":45,"phone":228,"phoneExt":10,"email":229},"Ralph Stephan von Bardeleben, MD, PhD","06131 17-7342","stephan.von_bardeleben@unimedizin-mainz.de",{"facility":231,"status":54,"city":232,"state":10,"zip":10,"country":233,"countryCode":234,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"Istituto Clinico Città di Brescia","Brescia","Italy","IT",{"type":60,"coordinates":236},[237,238],10.21472,45.53558,{"lat":238,"lon":237},[241],{"name":242,"role":45,"phone":243,"phoneExt":10,"email":244},"Marianna Adamo, MD, PhD","+39 030 2988","mariannaadamo@hotmail.com",{"facility":246,"status":54,"city":247,"state":10,"zip":10,"country":233,"countryCode":234,"cosmosGeoPoint":248,"geoPoint":252,"contacts":253},"San Raffaele Heart Valve Center Milan","Milan",{"type":60,"coordinates":249},[250,251],9.18951,45.46427,{"lat":251,"lon":250},[254],{"name":255,"role":45,"phone":256,"phoneExt":10,"email":257},"Francesco Maisano, MD, PhD","+39 340 357 3125","maisano.francesco@hsr.it",{"type":259,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[261,264,267,269,271,273,275,277,279,281,283,285,287,289,291,293],{"name":262,"class":263},"Centre Hospitalier Universitaire de Bordeaux, FRANCE","UNKNOWN",{"name":265,"class":266},"Materialise","INDUSTRY",{"name":268,"class":263},"Pie Medical Imaging",{"name":270,"class":6},"Clinique Pasteur Toulouse",{"name":272,"class":6},"Centre Cardiologique du Nord",{"name":274,"class":6},"Rennes University Hospital",{"name":276,"class":6},"San Raffaele University Hospital, Italy",{"name":278,"class":263},"Istituto clinico Città di Brescia",{"name":280,"class":6},"Unity Health Toronto",{"name":282,"class":6},"University Hospital, Marseille",{"name":284,"class":6},"University Hospital, Lille",{"name":286,"class":263},"Hospitaux Universitaires Paris Sud",{"name":288,"class":6},"Montefiore Medical Center",{"name":290,"class":6},"University Medical Center Mainz",{"name":292,"class":6},"Universitätsklinikum Hamburg-Eppendorf",{"name":294,"class":263},"Vancouver Hospital","100609357","enhanced-valves-interventions-and-safe-ai-generated-end-results-100609357",false,"NCT07213531","Enhanced Valves Interventions and Safe AI Generated End Results","ENVISAGE","Inclusion Criteria:\n\nPatients who have reached the age of legal majority under local laws.\n\n* For TAVI group: All patients who have had TAVI with a third generation transcatheter heart valve (THV), with an available pre-procedural optimal quality CT scan as defined by an ECG- gating CT with:\n\n  1. five to ten image volumes at cardiac phases from 5% to 95% R-R\n  2. 0.625 mm slice thickness\n  3. 0.625 mm spacing between slices\n  4. 0.88 mm in-plane pixel spacing\n* For TMVI group: Patients who have had a TMVI with a dedicated device and screen failures, with an available optimal quality CT scan.\n* For TTVI group: Patients who have had a TTVI with a dedicated device and screen failures, with an available optimal quality CT scan.\n* For M-TEER: All patient who have had a M-TEER with 1) G4 or newer iteration of MitraClip or 2) G2 or newer iteration of Pascal, with available pre-procedural TEE videos images from one of two vendors: Phillips or GE, with clear identifiable views of the Mitral valve, frame per second equal or higher than 40 frames per second, acceptable 3D reconstructions.\n* For T-TEER: All patient who have had a T-TEER with G4 or newer iteration of TriClip or 2) G2 or newer iteration of Pascal, with available pre-procedural TEE videos images from one of two vendors: Phillips or GE, with clear identifiable views of the Tricuspid valve, frame per second equal or higher than 40 frames per second, acceptable transgastric image with acceptable 3D reconstructions.\n\nExclusion Criteria:\n\n* For TAVI group: Valve-in-valve procedures\n* For TMVI group: Valve-in-valve and valve-in-ring procedures\n* For TTVI: Valve-in-valve and valve-in-ring procedures\n* For M-TEER: G3 or older MitraClip, G1 Pascal\n* For T-TEER: G3 Triclip, G1 Pascal","ALL","18 Years",{"count":305,"type":306},21000,"ESTIMATED","OBSERVATIONAL","This non-interventional study aims to use artificial intelligence to improve the prediction of transcatheter heart valve interventions and optimize patient outcomes. It is based on the analysis of retrospective data from various specialized centers worldwide.",[310,9,23,19,15,27,311,312],"Heart Valve Disease","Mitraclip","TriClip",[314,315,316,23,27,9,15,317,318],"Medical imaging","CT","Artificial intelligence","valvulopathy","predictive algorithms","2025-10-01",{"date":321,"type":322},"2025-10-09","ACTUAL",{"date":324,"type":322},"2024-05-01",{"date":326,"type":306},"2029-05",{"name":5,"class":6},15]