protocolSection identificationModule nctId: NCT06284837, orgStudyIdInfo id: HREC/99382/Alfred-2023, briefTitle: Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?, acronym: SAFER-TAVI, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-04, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: The Alfred, class: OTHER, collaborators name: Epworth Healthcare, collaborators name: Cabrini Health, descriptionModule briefSummary: Transcatheter aortic valve implantation (TAVI) is a well known safe treatment for severe aortic stenosis. To perform TAVI safely, there is a need for two vascular entry (access) sites: the primary and secondary access sites. While the femoral approach remains the most common site for primary access, secondary access (which is needed for guidance during the procedure) has drawn little attention in trials of TAVI. The two secondary access sites most commonly used are the radial (through an artery in the wrist) and femoral (through an artery in the groin) access sites. Observational studies comparing the two have shown a lower risk of complications with radial access compared to femoral access, but there are no randomized controlled data to confirm these findings. Accordingly, investigators aim to undertake a multicenter, randomized controlled trial among patients who are undergoing transfemoral TAVI, to assess if radial access is superior to femoral access as a secondary access site., conditionsModule conditions: Valve Stenoses, Aortic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 560, type: ESTIMATED, armsInterventionsModule interventions name: Access site, outcomesModule primaryOutcomes measure: All bleeding and vascular complications, secondaryOutcomes measure: All bleeding, secondaryOutcomes measure: All vascular complications, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: Stroke, secondaryOutcomes measure: Myocardial infarction, secondaryOutcomes measure: Major adverse cardiovascular events, secondaryOutcomes measure: Length of stay post-procedure, secondaryOutcomes measure: Overall procedure duration, secondaryOutcomes measure: Radiation dose, secondaryOutcomes measure: Conversion rate to alternative vascular access site, secondaryOutcomes measure: Tertiary site utilised to treat vascular complication, secondaryOutcomes measure: Failure to perform angiogram of primary access site at completion of TAVI, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alfred Health, status: RECRUITING, city: Melbourne, state: Victoria, zip: 3004, country: Australia, contacts name: Jennifer Zhou, MBBS, BMedSc, role: CONTACT, email: je.zhou@alfred.org.au, contacts name: Antony Walton, MBBS, role: PRINCIPAL_INVESTIGATOR, contacts name: Dion Stub, MBBS, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -37.814, lon: 144.96332, locations facility: Epworth Healthcare, status: NOT_YET_RECRUITING, city: Melbourne, state: Victoria, zip: 3121, country: Australia, contacts name: Jennifer Zhou, MBBS, BMedSc, role: CONTACT, email: je.zhou@alfred.org.au, contacts name: Antony Walton, MBBS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -37.814, lon: 144.96332, locations facility: Cabrini Health, status: NOT_YET_RECRUITING, city: Melbourne, state: Victoria, zip: 3144, country: Australia, contacts name: Jennifer Zhou, MBBS, BMedSc, role: CONTACT, email: je.zhou@alfred.org.au, contacts name: Dion Stub, MBBS, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -37.814, lon: 144.96332, hasResults: False