[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596255":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":26,"studyPopulation":19,"armGroups":27,"interventions":33,"overallOfficials":19,"centralContacts":39,"locations":19,"responsibleParty":45,"collaborators":19,"id":47,"slug":19,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":19,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":19,"enrollmentInfo":55,"targetDuration":19,"studyType":58,"phases":59,"briefSummary":60,"conditions":61,"keywords":19,"overallStatus":63,"whyStopped":19,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":19},{"fullName":5,"class":6},"Caranx Medical","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":19},[9],{"measure":10,"description":11,"timeFrame":12},"Investigational Device Safety","Exploratory evaluation of the technical robustness of the Investigational Device (TaviPilot Software) by evaluating the occurence of malfunctions while operating passively in parallel of the clinical procedure","Peroperative",[14,17],{"measure":15,"description":16,"timeFrame":12},"Investigational Device Performance","Assess the performance of the device by comparing the valve implantation depth measured by the TaviPilot Software with the depth estimated by the investigator who performed the procedure.",{"measure":15,"description":18,"timeFrame":12},"Assessment of clinician satisfaction related to device usability and performance using custom made questionnaires",null,{"allocation":21,"interventionModel":22,"interventionModelDescription":19,"primaryPurpose":23,"observationalModel":19,"timePerspective":19,"maskingInfo":24},"NA","SINGLE_GROUP","TREATMENT",{"masking":25,"maskingDescription":19,"whoMasked":19},"NONE","The study is a prospective mono-center single-arm study to evaluate primarily the feasibility and safety of TAVIPILOT augmented reality guidance software during Transcatheter Aortic Valve Replacement Procedures (TAVR) for severe aortic stenosis. A series of parameters will be analysed to determine whether TAVIPILOT is a safe tool for valve positioning.",[28],{"label":29,"type":30,"description":19,"interventionNames":31},"TAVR procedure with TAVIPILOT (investigational medical device)","EXPERIMENTAL",[32],"Device: TAVR using a guidance software",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":19},"DEVICE","TAVR using a guidance software","TAVR procedure with TAVIPILOT augmented reality guidance software operating in parallel on a separate screen in a blind setup, enabling clinicians to assess the analysis and recommendations provided by the software, either immediately after valve deployment or following the completion of the procedure.",[29],[40],{"name":41,"role":42,"phone":43,"phoneExt":19,"email":44},"Eric Sejor, MD","CONTACT","0033673335594","eric.sejor@caranx-medical.com",{"type":46,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100596255",false,"NCT07043075","First-in-Human (FIH) Study on the Feasibility and Safety of the TaviPilot Augmented Reality Guidance Software","First-in-Human (FIH) Study on the Feasibility and Safety of the TaviPilot Augmented Reality Guidance Software Operated in Parallel Setup During Transcatheter Aortic Valve Implantation (TAVI) Without Influencing Clinical Decision-Making","Inclusion Criteria:\n\n1. Patients aged ≥65\n2. Indicated for transfemoral TAVR for severe aortic stenosis","ALL","65 Years",{"count":56,"type":57},10,"ESTIMATED","INTERVENTIONAL",[21],"The trial aims to evaluate the feasibility and safety of Caranx Medical TAVIPILOT augmented reality guidance software during Transcatheter Aortic Valve Replacement Procedures.",[62],"Aortic Valve Stenosis","NOT_YET_RECRUITING","2025-06-20",{"date":66,"type":67},"2025-06-29","ACTUAL",{"date":69,"type":57},"2025-08-01",{"date":71,"type":57},"2026-05-30",{"name":5,"class":6}]