[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607848":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":22,"locations":32,"responsibleParty":70,"collaborators":10,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":10,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":85,"studyType":86,"phases":10,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Abbott Medical Devices","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1",null,"This study will enroll subjects of all genders from the population of patients qualifying for TAVI.",[13],"Device: Navitor Transcatheter Aortic Valve Implantation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Navitor Transcatheter Aortic Valve Implantation","Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System.",[9],[21],"TAVI",[23,28],{"name":24,"role":25,"phone":26,"phoneExt":10,"email":27},"Bart Janssens","CONTACT","+32471723201","bart.janssens@abbott.com",{"name":29,"role":25,"phone":30,"phoneExt":10,"email":31},"Alicia Kimber","+1 415-917-9696","alicia.kimber@abbott.com",[33,48,59],{"facility":34,"status":35,"city":36,"state":10,"zip":10,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Kokura Memorial Hospital","RECRUITING","Fukuoka","Japan","JP",{"type":40,"coordinates":41},"Point",[42,43],130.41667,33.6,{"lat":43,"lon":42},[46],{"name":47,"role":25,"phone":10,"phoneExt":10,"email":10},"Kenji Ando, Dr.",{"facility":49,"status":35,"city":50,"state":10,"zip":10,"country":37,"countryCode":38,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Shonan Kamakura General Hospital","Kanagawa",{"type":40,"coordinates":52},[53,54],139.91667,37.58333,{"lat":54,"lon":53},[57],{"name":58,"role":25,"phone":10,"phoneExt":10,"email":10},"Shigeru Saito, Dr.",{"facility":60,"status":35,"city":61,"state":10,"zip":10,"country":37,"countryCode":38,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Osaka Keisatsu Hospital","Osaka",{"type":40,"coordinates":63},[64,65],135.50107,34.69379,{"lat":65,"lon":64},[68],{"name":69,"role":25,"phone":10,"phoneExt":10,"email":10},"Yasuhiro Ichibori",{"type":71,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100607848","navitor-japan-study-100607848",false,"NCT07193888","Navitor Japan Study","Navitor Japan Post-Market Study","Inclusion Criteria:\n\n1. Patient is eligible per the current approved indication after Heart Team discussion and intended to undergo a Navitor TAVI procedure.\n2. The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the EC of the respective clinical site.\n3. The patient and the treating physician agree that the subject will return for all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n1. Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU).\n2. Life expectancy \\\u003C 12 months from the time of informed consent due to non-cardiac co-morbid conditions.\n3. In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and\u002For follow-up visits or that could impact scientific integrity of the study.\n4. Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated.\n5. Inability to tolerate antiplatelet\u002Fanticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated.\n6. Currently participating in an investigational drug or device study that may confound the results of this study.\n7. Anatomy that makes insertion and endovascular access to the aortic valve difficult and\u002For impossible.","ALL","18 Years","100 Years",{"count":83,"type":84},100,"ESTIMATED","12 Months","OBSERVATIONAL","The Navitor Japan Study is designed to evaluate the safety and performance of the Navitor™ valve used in combination with the FlexNav™ delivery system in a contemporary, real-world setting.",[89],"Severe Aortic Stenosis",[91,92,93,94],"NAVITOR","Transcatheter aortic valve implantation (TAVI)","Aortic Stenosis","Cardiovascular Disease","2026-05-21",{"date":97,"type":98},"2026-05-26","ACTUAL",{"date":100,"type":98},"2025-10-30",{"date":102,"type":84},"2028-08",{"name":5,"class":6},3]