[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644153":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":23,"studyPopulation":23,"armGroups":30,"interventions":37,"overallOfficials":23,"centralContacts":41,"locations":51,"responsibleParty":81,"collaborators":23,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":23,"enrollmentInfo":93,"targetDuration":23,"studyType":96,"phases":97,"briefSummary":98,"conditions":99,"keywords":23,"overallStatus":54,"whyStopped":23,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Caranx Medical","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":23},[9,13],{"measure":10,"description":11,"timeFrame":12},"The investigational device-related safety will also be assessed by verifying the absence of major technical malfunctions","Investigational Device Safety","Periprocedural",{"measure":14,"description":15,"timeFrame":12},"The primary objective is to evaluate investigational device-related safety, including the occurrence of investigational device-related conversion to open-heart surgery, investigational device-related valve embolization and investigational device-related.","Investigational device-related safety",[17,20],{"measure":18,"description":19,"timeFrame":12},"Device Performance","Assessment of the TAVIPILOT Robot ability to advance and retrieve the delivery system safely",{"measure":21,"description":22,"timeFrame":12},"Clinician satisfaction","The assessment of clinician satisfaction with the investigational devices, using specific customized questionnaires",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"NA","SINGLE_GROUP","TREATMENT",{"masking":29,"maskingDescription":23,"whoMasked":23},"NONE",[31],{"label":32,"type":33,"description":34,"interventionNames":35},"Use of tele-operated TAVIPILOT Software and Robot during the procedure","EXPERIMENTAL","TAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR.",[36],"Device: TAVR procedure with TAVIPILOT Software and tele-operated robot by Caranx Medical enhancing the precision of transcatheter aortic valve positioning during TAVR.",[38],{"type":39,"name":34,"description":34,"armGroupLabels":40,"otherNames":23},"DEVICE",[32],[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Dr Eric Sejor","CONTACT","09 82 24 85 61","+33","eric.sejor@caranx-medical.com",{"name":49,"role":44,"phone":23,"phoneExt":23,"email":50},"Christophe Naz","christophe.naz.pro@gmail.com",[52,71],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Macquarie University Hospital","RECRUITING","Sydney","New South Wales","2109","Australia","AU",{"type":61,"coordinates":62},"Point",[63,64],151.20732,-33.86785,{"lat":64,"lon":63},[67],{"name":68,"role":44,"phone":69,"phoneExt":23,"email":70},"Amy Johnson Clinical Trial Coordinator","+61(4) 79 187 608","amy.johnson@mq.edu.au",{"facility":72,"status":54,"city":55,"state":56,"zip":23,"country":58,"countryCode":59,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"St Vincent's Hospital Sydney",{"type":61,"coordinates":74},[63,64],{"lat":64,"lon":63},[77],{"name":78,"role":44,"phone":79,"phoneExt":23,"email":80},"Erika O'Dea Research and Structural Heart Coordinator","+61 (4) 12 806 682","erika.odea@svha.org.au",{"type":82,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100644153","trial-of-device-that-is-not-approved-or-cleared-by-the-us-fda-100644153",false,"NCT07664163","SAIRO - Feasibility and Safety of the Tele-operated TAVIPILOT Robot Guided by TAVIPILOT Software","SAIRO - Feasibility and Safety of the Tele-operated TAVIPILOT Robot Guided by TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR\u002FTAVI)","SAIRO","Inclusion Criteria:\n\n1. Patients aged ≥65\n2. Indicated for transfemoral TAVR for severe aortic stenosis","ALL","65 Years",{"count":94,"type":95},10,"ESTIMATED","INTERVENTIONAL",[25],"The TAVIPILOT robotic platform, developed by Caranx Medical is an advanced intraoperative robotic assistance system designed to enhance the precision of transcatheter aortic valve positioning during TAVR. The TAVIPILOT robotic platform includes the TAVIPILOT Software, Robot (when controlled by the user) and Loop (when guided by the Software). The system integrates with standard procedural workflows and enables remote manipulation of delivery system components, allowing for controlled, stable, and reproducible movements. TAVIPILOT devices facilitate accurate valve alignment and deployment, reducing operator variability. The robot is compatible with commercially approved balloon-expandable transcatheter heart valves (Sapien 3 and Ultra, Edwards Lifesciences, USA) and standard catheterization lab infrastructure.",[100],"TAVI(Transcatheter Aortic Valve Implantation)","2026-09-04",{"date":103,"type":104},"2026-09-09","ACTUAL",{"date":106,"type":95},"2026-09-10",{"date":108,"type":95},"2027-05-01",{"name":5,"class":6},2]