[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100194339":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":38,"studyPopulation":39,"armGroups":11,"interventions":11,"overallOfficials":40,"centralContacts":45,"locations":50,"responsibleParty":90,"collaborators":11,"id":94,"slug":11,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":11,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":11,"enrollmentInfo":102,"targetDuration":105,"studyType":106,"phases":11,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":52,"whyStopped":11,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Heinrich-Heine University, Duesseldorf","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"Assessment of diameters of the aortic annulus using the different imaging modalities",null,"baseline",{"measure":14,"description":11,"timeFrame":12},"Implantation depth (ID) measured from NCC in fluoroscopic view",[16,18,20,22,24],{"measure":17,"description":11,"timeFrame":12},"left ventricular contrast injection",{"measure":19,"description":11,"timeFrame":12},"Comparison of pre-procedural TAVI-imaging for the assessment of the left ventricular outflow tract (LVOT).",{"measure":21,"description":11,"timeFrame":12},"mean pressure gradient",{"measure":23,"description":11,"timeFrame":12},"paravalvular aortic regurgitation",{"measure":25,"description":11,"timeFrame":12},"bleeding and vascular access site complications",[27,30,32,34],{"measure":28,"description":11,"timeFrame":29},"Major Adverse Cardiac Event","1 month, 3 months and 12 months",{"measure":31,"description":11,"timeFrame":29},"Hospitalisation",{"measure":33,"description":11,"timeFrame":29},"Mortality",{"measure":35,"description":11,"timeFrame":29},"blood samples",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":37,"timePerspective":6,"maskingInfo":11},"COHORT","Transcatheter aortic valve implantation (TAVI) is an emerging alternative therapy for aortic stenosis for patients ineligible for open heart surgery or at high risk for perioperative complications. Pre-procedural imaging of the aortic root is essential for selection of the correct valve prosthesis and to minimize complications as prosthesis mismatch, possibly subsequent embolization, coronary obstruction, annulus rupture or severe aortic regurgitation.\n\nThe aim of the study is to compare the different imaging modalities for aortic root measurements.\n\nAortic root imaging will be performed prior to TAVI-procedure. The contrast injection will be performed either into the aorta or into the left ventricle. The datasets will be assessed by blinded-independent observers in a multi-planar reconstruction view.\n\nThe study will be performed retrospectively (2009-2012) and prospectively starting 2013.\n\nSubstudy: \"Real-World Experience with Implantation Depth Optimization according to 2020 Recommendations for Evolut R Self-Expanding Transcatheter Aortic Valve: the Düsseldorf Best Practice Trial.\" Aortic valve stenosis treated by transcatheter aortic valve replacement (TAVR) is one of the most fast-growing sections in interventional cardiology. The Heart Center Düsseldorf is a high-volume center for treatment of patients suffering of aortic stenosis treated by TAVR, so we have a great interest in further investigation of process optimizing and improvement. Therefore, we will focus on optimization of implantation depth (ID) according to Medtronic®'s best practice recommendations for TAVR deployment in July 2020 regarding new-generation devices Medtronic® CoreValve Evolut. Optimal ID is an important condition for hemodynamic and clinical outcome due to increased risk of paravalvular leakage or even valve embolization in implantation that is located too high, whereas deep implantation is associated with more aortic regurgitation an increased risk of conduction disturbances associated with higher rates of permanent pacemaker implantation. The aim of this single-center observational study is to investigate short-term clinical performance, safety and efficiency outcomes in patients undergoing transfemoral TAVR regarding Medtronic®'s best practice advices of July 2020 for TAVR deployment with CoreValve Evolut.","patients with aortic valve stenosis screened for TAVI",[41],{"name":42,"affiliation":43,"role":44},"Malte Kelm, MD","Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf","STUDY_DIRECTOR",[46],{"name":42,"role":47,"phone":48,"phoneExt":11,"email":49},"CONTACT","0049 211 81 18800","CTSU@med.uni-duesseldorf.de",[51],{"facility":43,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Düsseldorf","North Rhine-Westphalia","40225","Germany","DE",{"type":59,"coordinates":60},"Point",[61,62],6.77927,51.22319,{"lat":62,"lon":61},[65,66,69,71,74,76,78,80,82,84,86,88],{"name":42,"role":47,"phone":48,"phoneExt":11,"email":49},{"name":67,"role":47,"phone":48,"phoneExt":11,"email":68},"Rabea Wagstaff, MA","ctsu@med.uni-duesseldorf.de",{"name":42,"role":70,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"name":72,"role":73,"phone":11,"phoneExt":11,"email":11},"Florian Bönner, MD","SUB_INVESTIGATOR",{"name":75,"role":73,"phone":11,"phoneExt":11,"email":11},"Katharina Hellhammer, MD",{"name":77,"role":73,"phone":11,"phoneExt":11,"email":11},"Tobias Zeus, MD",{"name":79,"role":73,"phone":11,"phoneExt":11,"email":11},"Ralf Westenfeld, MD",{"name":81,"role":73,"phone":11,"phoneExt":11,"email":11},"Verena Veulemans, MD",{"name":83,"role":73,"phone":11,"phoneExt":11,"email":11},"Kathrin Klein, MD",{"name":85,"role":73,"phone":11,"phoneExt":11,"email":11},"Christian Jung, MD",{"name":87,"role":73,"phone":11,"phoneExt":11,"email":11},"Oliver Maier, MD",{"name":89,"role":73,"phone":11,"phoneExt":11,"email":11},"Shazia Afzal, MD",{"type":91,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Klinik für Kardiologie, Pneumologie und Angiologie","Director Division of Cardiology, Pulmonary Diseases, Vascular Medicine","100194339",false,"NCT01805739","Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation","Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation (TAVI)","Inclusion Criteria:\n\n* aortic valve stenosis\n* screened for TAVI\n* written informed consent\n\nExclusion Criteria:\n\n* unconsciousness, not able to consent","ALL","18 Years",{"count":103,"type":104},5000,"ESTIMATED","12 Months","OBSERVATIONAL","Transcatheter aortic valve implantation (TAVI) is an emerging alternative therapy for aortic stenosis for patients ineligible for open heart surgery or at high risk for perioperative complications. Pre-procedural imaging of the aortic root is essential for selection of the correct valve prosthesis and to minimize complications as prosthesis mismatch, possibly subsequent embolization, coronary obstruction, annulus rupture or severe aortic regurgitation.\n\nThe aim of the study is to compare the different imaging modalities for aortic root measurements.\n\nAortic root imaging will be performed prior to TAVI-procedure. The contrast injection will be performed either into the aorta or into the left ventricle. The datasets will be assessed by blinded-independent observers in a multi-planar reconstruction view.\n\nThe study will be performed retrospectively (2009-2012) and prospectively starting 2013.",[109],"Aortic Valve Stenosis",[111,112,113,114,115,116],"transcatheter aortic valve implantation","CT","MRI","angiography","echocardiography","rotational C-arm CT","2020-10-28",{"date":119,"type":120},"2020-10-30","ACTUAL",{"date":122,"type":11},"2013-01",{"date":124,"type":104},"2030-12",{"name":92,"class":6},1]