[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609677":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":25,"responsibleParty":40,"collaborators":25,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":25,"maxAge":25,"enrollmentInfo":53,"targetDuration":25,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":67,"whyStopped":25,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":25},{"fullName":5,"class":6},"Oslo University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard rotation of delevery system in the descending aorta at LAO 25 degree","ACTIVE_COMPARATOR","LAO 25",[13],"Device: Implantation of Evolut FX pluss TAVI device from Medtronic in LAO 25",{"label":15,"type":10,"description":16,"interventionNames":17},"Rotation of delivery system in the descending aorta with patient-specific degree obtained from CT","Patient specific degree",[18],"Device: Implantation of Evolut FX pluss TAVI device from Medtronic in patient specific degree.",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Implantation of Evolut FX pluss TAVI device from Medtronic in LAO 25","In this arm the HAT marker will be placed in the outer curvature of descending aorta in LAO 25 degree.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Implantation of Evolut FX pluss TAVI device from Medtronic in patient specific degree.","In this arm the HAT marker will be placed in the outer curvature of descending aorta in patient specific degree.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Ahmed Al-Ani, MD\u002FPHD candidate","CONTACT","004792831213","aalani@ous-hf.no",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Trygve Hall, MD\u002FPHD","004747500700","tryhal@ous-hf.no",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Ahmed Al-Ani","MD","100609677","optimization-of-commissural-alignment-during-transcatheter-aortic-valve-implantation-with-evolut-fx-100609677",false,"NCT07217691","Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+","Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+. A Randomized, Prospective Study.","ALIGN-EFX","Inclusion Criteria:\n\n* Patients with severe aortic stenosis indicated for TAVI after heart team meeting.\n* Age ≥65 years.\n* Patients planned by the TAVI team to receive a self-expandable valve (Evolut FX+ valve).\n* Patients providing informed consent.\n\nExclusion Criteria:\n\n* Severe peripheral vascular disease preventing transfemoral access.\n* Prior aortic valve replacement or bicuspid valve.\n* Severely reduced kidney function (estimated glomerular filtration rate \\\u003C30).","ALL",{"count":54,"type":55},40,"ESTIMATED","INTERVENTIONAL",[58],"NA","Purpose of the Study The purpose of this study is to investigate how a transcatheter aortic valve (TAVI, biological valve prosthesis) can best be positioned in order to avoid blockage of the coronary arteries by the valve material after implantation.\n\nMethod The study will include patients undergoing TAVI. Participants will be randomized, meaning that it will be determined by chance which of two established implantation techniques is used. Both techniques are already part of routine clinical practice.\n\nExaminations After the procedure, a CT scan will be performed to evaluate the position of the valve in relation to the coronary arteries. This CT scan is the only additional examination beyond today's standard clinical practice.\n\nSignificance If one of the techniques proves to provide better positioning of the valve, this method may be recommended as standard practice in future treatment. The study will therefore contribute to improved patient safety and treatment quality, as well as increase knowledge about optimal positioning and implantation techniques in TAVI.",[61,62,63],"Aortic Stenosis","Trans-catheter Aortic Valve Implantation","Commissural Alignment",[65,66],"TAVI","Commissural alignment","NOT_YET_RECRUITING","2025-10-14",{"date":70,"type":71},"2025-10-16","ACTUAL",{"date":73,"type":55},"2025-11-01",{"date":75,"type":55},"2026-05-01",{"name":5,"class":6}]