[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"commissural-alignment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:commissural-alignment":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"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":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Aortic Stenosis","Trans-catheter Aortic Valve Implantation","Commissural Alignment",[30,31],"TAVI","Commissural alignment","NOT_YET_RECRUITING","2025-10-14",{"date":35,"type":36},"2025-10-16","ACTUAL",{"date":38,"type":20},"2025-11-01",{"date":40,"type":20},"2026-05-01",{"name":42,"class":43},"Oslo University Hospital","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":64,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100584966","tavr-the-impact-of-prothesis-positioning-on-valvular-and-coronary-hemodynamics-100584966","NCT06896227","TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics","Transcatheter Aortic Valve Implantation (TAVR): The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics","Inclusion Criteria\n\n\\- Patients who have undergone transfemoral transcatheter aortic valve replacement (TAVR).\n\nExclusion Criteria\n\n* Any access route other than transfemoral.\n* Valve-in-valve procedures.\n* History of prior bioprosthetic valve implantation.\n* Presence of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) system.\n* Diagnosis of liver cirrhosis.\n* Esophageal disorders, including but not limited to esophageal varices.\n* Thrombocytopenia or coagulation disorders.\n* Any medical or psychiatric condition (e.g., dementia, alcoholism, or substance abuse) that may impair the ability to provide informed consent or interfere with study procedures, including follow-up visits.",{"count":52,"type":20},100,[23],"The aim of this clinical study is to learn more about the effects of TAVR-prosthesis positioning on hemodynamics and the coronary arteries.\n\nThe main questions it aims to answer are:\n\n1. Does the cardiac magnetic resonance imaging and the echocardiography imaging provide an equivalent alternative to the computer tomography which is the state of the art in evaluating commissural alignment?\n2. What effect does the position of the valve on the annular level have, especially its symmetrical and commissural position, on valvular and aortic blood flow characteristics?\n3. What is the influence of symmetrical position and the presence of a commissural alignment on the coronary flow after transcatheter aortic valve replacement?",[56,57,28,58,59,60,61,62,63],"Transcatheter Aortic Valve Replacement","Transcatheter Aortic Valve Implantation","Commissural Misalignment","Symmetry","Prothesis Positioning","Prosthesis Durability","Aortic Valve Stenosis","Aortic Valve Disease",[65,30,31,59,66,67,68,69],"TAVR","Prothesis positioning","cMRI","4D Flow","TEE","RECRUITING","2025-03-19",{"date":73,"type":36},"2025-03-26",{"date":75,"type":36},"2024-10-22",{"date":77,"type":20},"2025-12-31",{"name":79,"class":43},"Heinrich-Heine University, Duesseldorf",1]