protocolSection identificationModule nctId: NCT06342635, orgStudyIdInfo id: HYD/DENMARK-001/2023, briefTitle: Hydra Single-centre Experience - Copenhagen, Denmark, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Sahajanand Medical Technologies Limited, class: INDUSTRY, collaborators name: Qmed Consulting A/S, descriptionModule briefSummary: The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. Additionally, the study will assess the role of geometry in the development of new conduction abnormalities based on the analysis of post-operative CT scan at 1-month in patients who had undergone transcatheter aortic valve replacement with a self-expanding Hydra THV series., conditionsModule conditions: Aortic Valve Stenosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Hydra Transcatheter Aortic Valve (THV) Series, outcomesModule primaryOutcomes measure: Primary safety endpoint, primaryOutcomes measure: Primary performance endpoint, secondaryOutcomes measure: Technical success, secondaryOutcomes measure: Cardiovascular mortality, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: All stroke, secondaryOutcomes measure: Disabling stroke, secondaryOutcomes measure: Myocardial infarction, secondaryOutcomes measure: Major vascular complication, secondaryOutcomes measure: Acute kidney injury, secondaryOutcomes measure: New permanent pacemaker implantation due to procedure related conduction abnormalities, secondaryOutcomes measure: New-onset atrial fibrillation, secondaryOutcomes measure: Coronary artery obstruction requiring intervention, secondaryOutcomes measure: Re-hospitalization for procedure- or valve-related causes, secondaryOutcomes measure: Mean aortic valve gradient, secondaryOutcomes measure: Effective Orifice Area (EOA), secondaryOutcomes measure: Paravalvular leak, secondaryOutcomes measure: New York Heart Association (NYHA) functional class, secondaryOutcomes measure: Quality-of-life evaluation, secondaryOutcomes measure: Bioprosthetic Valve Failure (BVF), secondaryOutcomes measure: Bioprosthetic valve dysfunction (BVD), secondaryOutcomes measure: Stroke or peripheral embolism, secondaryOutcomes measure: VARC-3 Type 3-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents used specifically for valve-related concerns, secondaryOutcomes measure: Rates of Hypoattenuated Leaflet Thickening (HALT), secondaryOutcomes measure: Rates of Reduced leaflet motion (RLM), secondaryOutcomes measure: Commissural alignment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Copenhagen University Hospital, Rigshospitalet, city: Copenhagen, country: Denmark, contacts name: Dr. Ole De Backer, role: CONTACT, contacts name: Dr. Ole De Backer, Copenhagen University Hospital, Rigshospitalet, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False