[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646149":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":25,"locations":19,"responsibleParty":34,"collaborators":19,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":19,"enrollmentInfo":46,"targetDuration":19,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":59,"whyStopped":19,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":19},{"fullName":5,"class":6},"Abbott Medical Devices","INDUSTRY",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"Transcatheter valve replacement therapy","EXPERIMENTAL",[12],"Device: Prospective, single-arm, multi-center study.",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Prospective, single-arm, multi-center study.","This intervention is distinguished by the use of the Encantor TAVI System, a transcatheter valve replacement therapy specifically designed for patients with symptomatic severe native calcific aortic stenosis who are considered appropriate candidates by a multidisciplinary heart team. This device is intended to provide a minimally invasive alternative to surgical aortic valve replacement.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Ashish Oza","Abbott Structural Heart","STUDY_DIRECTOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Nadia Bouhdi","CONTACT","+32479941037","nadia.bouhdi@abbott.com",{"name":32,"role":28,"phone":19,"phoneExt":19,"email":33},"Lauren Harvey","lauren.harvey@abbott.com",{"type":35,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100646149","validation-of-anatomy-specific-aortic-valve-implantation-guided-by-software-using-encantor-100646149",false,"NCT07696182","Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR","VOYAGER CE Clinical Trial : Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR","VOYAGER CE","Inclusion Criteria:\n\n* Subject identified as appropriate for transcatheter heart valve intervention therapy for the treatment of symptomatic, severe aortic stenosis.\n* Subject is of legal age for consent (18 years old).\n* Willing to return for required follow-up visits and assessments\n\nExclusion Criteria:\n\n* Pregnant or nursing subjects.\n* Need for emergency surgery for any reason\n* Anatomic or comorbid conditions\n* Currently participating in an investigational drug or device study that has not reached the primary endpoint or may confound the results of this trial","ALL","18 Years",{"count":47,"type":48},150,"ESTIMATED","INTERVENTIONAL",[51],"NA","VOYAGER CE Clinical Study using the Encantor TAVI System.",[54,55],"Severe Native Calcific Aortic Stenosis","Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis",[57,58],"transcatheter valve replacement therapy","symptomatic heart disease","NOT_YET_RECRUITING","2026-07-06",{"date":62,"type":63},"2026-07-10","ACTUAL",{"date":65,"type":48},"2026-11-30",{"date":67,"type":48},"2038-12-30",{"name":5,"class":6}]