[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512761":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":23,"responsibleParty":65,"collaborators":67,"id":71,"slug":7,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":7,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":83,"studyType":84,"phases":7,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":26,"whyStopped":7,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Sahajanand Medical Technologies Limited","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","Hydra Transcatheter Aortic Valve System","The Hydra device is self-expanding transcatheter aortic valve consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.",[14],{"name":15,"affiliation":16,"role":17},"Dr. Angelo Cioppa","Montevergine Clinic, Mercogliano, Italy","PRINCIPAL_INVESTIGATOR",[19],{"name":15,"role":20,"phone":21,"phoneExt":7,"email":22},"CONTACT","+390825705131","emodinamica@clinicamontevergine.it",[24,36,46,56],{"facility":25,"status":26,"city":27,"state":7,"zip":28,"country":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":7},"Fondazione Poliambulanza Istituto","RECRUITING","Brescia","25124","Italy",{"type":31,"coordinates":32},"Point",[33,34],10.21472,45.53558,{"lat":34,"lon":33},{"facility":16,"status":26,"city":37,"state":7,"zip":38,"country":29,"cosmosGeoPoint":39,"geoPoint":43,"contacts":44},"Mercogliano","83013",{"type":31,"coordinates":40},[41,42],14.74491,40.92157,{"lat":42,"lon":41},[45],{"name":15,"role":20,"phone":7,"phoneExt":7,"email":7},{"facility":47,"status":48,"city":49,"state":7,"zip":50,"country":29,"cosmosGeoPoint":51,"geoPoint":55,"contacts":7},"IRCCS Ospedale Galeazzi-Sant'Ambrogio","NOT_YET_RECRUITING","Milan","20157",{"type":31,"coordinates":52},[53,54],12.59836,42.78235,{"lat":54,"lon":53},{"facility":57,"status":48,"city":58,"state":7,"zip":59,"country":29,"cosmosGeoPoint":60,"geoPoint":64,"contacts":7},"Università degli studi di Padova","Padova","35122",{"type":31,"coordinates":61},[62,63],11.14261,44.38225,{"lat":63,"lon":62},{"type":66,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[68],{"name":69,"class":70},"Clinica Di Montevergine","OTHER","100512761",false,"NCT05956652","Hydra Registry - Italy Experience","Observational Study on the Efficacy and Safety of Transcatheter Implantation of Hydra Biological Aortic Prosthesis","Inclusion Criteria:\n\n* Patients with severe symptomatic native aortic valve stenosis and candidates for the TAVI procedure based on the evaluation of the Heart Team\n* Ability to understand and provide informed consent for inclusion in the study\n\nExclusion Criteria:\n\n* Contraindication to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis.\n* Refusal by the patient to participate in the study\n* High probability of non-adherence to required follow-ups","ALL","18 Years","99 Years",{"count":81,"type":82},500,"ESTIMATED","5 Years","OBSERVATIONAL","Hydra-IT is a multicenter observational study aim to collect clinical, procedural and follow-up data and evaluate the short, medium and long term results of Hydra TAVI System in patient with severe aortic stenosis.",[87],"Aortic Valve Stenosis",[87,89,90],"TAVI","Hydra","2026-04-22",{"date":93,"type":94},"2026-04-27","ACTUAL",{"date":96,"type":94},"2023-07-01",{"date":98,"type":82},"2029-07-31",{"name":5,"class":6},4]