[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620613":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":18,"responsibleParty":35,"collaborators":37,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":10,"enrollmentInfo":53,"targetDuration":56,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":21,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"IRCCS Policlinico S. Donato","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Aortic Stenosis Patients",null,"This Study will enroll subjects of all genders who have symptomatic, severe AS, either in native or in a surgical bioprosthetic valve and are indicated for TAVI implantation. The latter can also be predominantly regurgitant to be suitable for enrolment. Subjects must meet all general eligibility criteria for the TAVI procedure and provide written informed consent prior to sites collecting any clinical data for this Study.\n\nThe operative risk determination of study candidates will be done by the local heart team. The assessment of surgical risk will include the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Risk Calculator score and\u002For EuroSCORE II, indices of frailty, and comorbidities not captured by risk calculators, as described below, and current TAVI practice guidelines.",[13],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Luca Testa, Principal Investigator","CONTACT","00390252774980","luca.testa@grupposandonato.it",[19],{"facility":20,"status":21,"city":22,"state":23,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"IRCCS Policlinico San Donato","RECRUITING","San Donato Milanese","Lombardy","20097","Italy","IT",{"type":28,"coordinates":29},"Point",[30,31],9.26838,45.41047,{"lat":31,"lon":30},[34],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},{"type":36,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[38,41],{"name":39,"class":40},"Meditrial SrL","INDUSTRY",{"name":42,"class":40},"Abbott","100620613","international-multicenter-study-of-the-navitornavitor-vision-transcatheter-aortic-valve-platform-100620613",false,"NCT07359898","International Multicenter Study of the Navitor\u002FNavitor Vision Transcatheter Aortic Valve Platform","International Multicenter Study of the Navitor\u002FNavitor Vision Transcatheter Aortic Valve Platform (The Intensive Study)","Intensive","Inclusion Criteria:\n\n1. Subject is referred to receive a Navitor\u002FNavitor Vision TAVI according to the local Heart Team. The Heart Team determines the indication to TAVI with Navitor\u002FNavitor Vision before the possible enrolment and independently from the study.\n2. Subject is of legal age for consent in the host country.\n3. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Ethics Committee (EC) of the respective clinical site.\n\nExclusion Criteria:\n\n1. Pregnant or nursing subjects\n2. Need for emergency surgery for any reason\n3. Contraindications to Navitor\u002FNavitor Vision TAVI according to the IFU:\n\n   1. Any sepsis, including active endocarditis\n   2. Any evidence of left ventricular or atrial thrombus\n   3. Vascular conditions (i.e., stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve impossible\n   4. Non-calcified aortic annulus\n   5. Any leaflet configuration other than tricuspid\n   6. Inability to tolerate antiplatelet\u002Fanticoagulant therapy\n4. Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, individuals with severe dementia or individuals without legal authority\n5. Individuals who are unable to read or write","ALL","18 Years",{"count":54,"type":55},1000,"ESTIMATED","5 Years","OBSERVATIONAL","INTENSIVE is a prospective, single-arm, multi-center, international, investigator-initiated study of the Navitor\u002FNavitor Vision Transcatheter Aortic Valve (Navitor\u002FNavitor Vision Valve) in patients with symptomatic, severe native aortic stenosis to monitor the outcomes of this valve in a real-world clinical setting.",[60],"Severe Native Aortic Stenosis",[62,63,64,65],"Aortic Stenosis","TAVI","Navitor","Portico","2026-01-12",{"date":68,"type":69},"2026-01-22","ACTUAL",{"date":71,"type":69},"2025-10-11",{"date":73,"type":55},"2031-10",{"name":5,"class":6},1]