[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512761":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":23,"responsibleParty":66,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":7,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":85,"studyType":86,"phases":7,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":26,"whyStopped":7,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"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",[24,37,47,57],{"facility":25,"status":26,"city":27,"state":7,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":7},"Fondazione Poliambulanza Istituto","RECRUITING","Brescia","25124","Italy","IT",{"type":32,"coordinates":33},"Point",[34,35],10.21472,45.53558,{"lat":35,"lon":34},{"facility":16,"status":26,"city":38,"state":7,"zip":39,"country":29,"countryCode":30,"cosmosGeoPoint":40,"geoPoint":44,"contacts":45},"Mercogliano","83013",{"type":32,"coordinates":41},[42,43],14.74491,40.92157,{"lat":43,"lon":42},[46],{"name":15,"role":20,"phone":7,"phoneExt":7,"email":7},{"facility":48,"status":49,"city":50,"state":7,"zip":51,"country":29,"countryCode":30,"cosmosGeoPoint":52,"geoPoint":56,"contacts":7},"IRCCS Ospedale Galeazzi-Sant'Ambrogio","NOT_YET_RECRUITING","Milan","20157",{"type":32,"coordinates":53},[54,55],12.59836,42.78235,{"lat":55,"lon":54},{"facility":58,"status":49,"city":59,"state":7,"zip":60,"country":29,"countryCode":30,"cosmosGeoPoint":61,"geoPoint":65,"contacts":7},"Università degli studi di Padova","Padova","35122",{"type":32,"coordinates":62},[63,64],11.14261,44.38225,{"lat":64,"lon":63},{"type":67,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[69],{"name":70,"class":71},"Clinica Di Montevergine","OTHER","100512761","hydra-registry---italy-experience-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":83,"type":84},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.",[89],"Aortic Valve Stenosis",[89,91,92],"TAVI","Hydra","2026-04-22",{"date":95,"type":96},"2026-04-27","ACTUAL",{"date":98,"type":96},"2023-07-01",{"date":100,"type":84},"2029-07-31",{"name":5,"class":6},4]