[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555091":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":29,"responsibleParty":73,"collaborators":75,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":10,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":92,"studyType":93,"phases":10,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Sahajanand Medical Technologies Limited","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Severe aortic valve stenosis",null,"Hydra transcatheter aortic valve (THV) series",[13],"Device: Hydra transcatheter aortic valve (THV) series",[15],{"type":16,"name":11,"description":17,"armGroupLabels":18,"otherNames":10},"DEVICE","The Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.",[9],[20],{"name":21,"affiliation":22,"role":23},"Dr. Javaid Iqbal, MRCP, PhD","Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust","PRINCIPAL_INVESTIGATOR",[25],{"name":21,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","7788438471","J.Iqbal@sheffield.ac.uk",[30,45,55,64],{"facility":22,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Sheffield","Yorkshire","S5 7AU","United Kingdom","UK",{"type":38,"coordinates":39},"Point",[40,41],-1.4659,53.38297,{"lat":41,"lon":40},[44],{"name":21,"role":26,"phone":27,"phoneExt":10,"email":28},{"facility":46,"status":47,"city":48,"state":10,"zip":49,"country":35,"countryCode":36,"cosmosGeoPoint":50,"geoPoint":54,"contacts":10},"Royal Victoria Hospital","NOT_YET_RECRUITING","Belfast","BT12 6BA",{"type":38,"coordinates":51},[52,53],-5.92541,54.59682,{"lat":53,"lon":52},{"facility":56,"status":47,"city":57,"state":10,"zip":58,"country":35,"countryCode":36,"cosmosGeoPoint":59,"geoPoint":63,"contacts":10},"Royal Papworth","Cambridge","CB2 0AY",{"type":38,"coordinates":60},[61,62],0.11667,52.2,{"lat":62,"lon":61},{"facility":65,"status":31,"city":66,"state":10,"zip":67,"country":35,"countryCode":36,"cosmosGeoPoint":68,"geoPoint":72,"contacts":10},"Castle Hill Hull","Cottingham","HU16 5JQ",{"type":38,"coordinates":69},[70,71],-0.7554,52.50243,{"lat":71,"lon":70},{"type":74,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[76],{"name":77,"class":78},"Psephos Biomedica","UNKNOWN","100555091","hydra-registry---uk-100555091",false,"NCT06507579","Hydra Registry - UK","Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve","Inclusion Criteria:\n\n1. Patients with severe aortic stenosis eligible for transfemoral TAVI procedure as per local Heart Team evaluation\n2. Full understanding and willing to provide informed consent to study enrolment\n3. Age ≥ 18 years\n\nExclusion Criteria:\n\n1. Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)\n2. Refusal to provide informed consent to study enrolment\n3. Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI\n4. Patients with significant calcification of the aortic annulus and in the Left Ventricular Outflow Tract (LVOT), or\u002Fand excess calcium within each cusp, or those who are deemed unsuitable for the Hydra THV series based on the clinical judgment of the Investigator.","ALL","18 Years","99 Years",{"count":90,"type":91},250,"ESTIMATED","1 Year","OBSERVATIONAL","The study will evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) using the Hydra transcatheter aortic heart valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. This will include an evaluation of the preservation of coronary access post implant by attempting to selectively engage both the right and left coronary arteries through standardised angiographic views.\n\nThe study will also examine the utility of 72 hours of post discharge remote ambulatory continuous electrocardiogram (ECG) monitoring using the novel Checkpoint Cardio System where it is clinically appropriate.",[96],"Aortic Valve Stenosis",[98],"Aortic Valve Stenosis, TAVI, Hydra","2026-04-22",{"date":101,"type":102},"2026-04-27","ACTUAL",{"date":104,"type":102},"2024-07-11",{"date":106,"type":91},"2026-08-01",{"name":5,"class":6},4]