[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474540":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":161,"collaborators":23,"id":164,"slug":165,"hasResults":166,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":166,"sex":172,"minAge":173,"maxAge":23,"enrollmentInfo":174,"targetDuration":23,"studyType":177,"phases":178,"briefSummary":180,"conditions":181,"keywords":23,"overallStatus":63,"whyStopped":23,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},{"fullName":5,"class":6},"Institut universitaire de cardiologie et de pneumologie de Québec, University Laval","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Doppler-echocardiography","Following valve implantation, further intervention will be based on Doppler-echocardiographic measurements.",[12],"Procedure: Doppler-echocardiography",{"label":14,"type":6,"description":15,"interventionNames":16},"Invasive hemodynamic measurements","Following valve implantation, further interventions will be based on invasive hemodynamic measurements (with simultaneous aortic and ventricular pressure recording).",[17],"Procedure: Invasive hemodynamic measurements",[19,24],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"PROCEDURE","The TAVR (valve-in-valve) procedure will be performed with the SAPIEN 3 Ultra valve, with valve sizing according to current manufacturer recommendations. Following valve implantation, further intervention will be based on Doppler-echocardiographic measurements. Balloon post-dilation with a non-compliant balloon will be performed in the presence of a residual mean gradient ≥20 mmHg as assessed by Doppler-echocardiography.",[9],null,{"type":20,"name":14,"description":25,"armGroupLabels":26,"otherNames":23},"The TAVR (valve-in-valve) procedure will be performed with the SAPIEN 3 Ultra valve, with valve sizing according to current manufacturer recommendations. Following valve implantation, further interventions will be based on invasive hemodynamic measurements (with simultaneous aortic and ventricular pressure recording). Balloon post-dilation will be performed with a non-compliant balloon in the presence of a mean residual gradient ≥20 mmHg as assessed by hemodynamic measurements.",[14],[28],{"name":29,"affiliation":5,"role":30},"Josep Rodés-Cabau, MD","PRINCIPAL_INVESTIGATOR",[32,36],{"name":29,"role":33,"phone":34,"phoneExt":23,"email":35},"CONTACT","418-656-8711","josep.rodes@criucpq.ulaval.ca",{"name":37,"role":33,"phone":34,"phoneExt":38,"email":39},"Emilie Pelletier Beaumont, MSc","3929","emilie.pelletier-beaumont@criucpq.ulaval.ca",[41,61,78,94,111,127,144],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University of California","NOT_YET_RECRUITING","San Francisco","California","94143","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-122.41942,37.77493,{"lat":53,"lon":52},[56,58],{"name":57,"role":33,"phone":23,"phoneExt":23,"email":23},"Sammy Elmariah",{"name":59,"role":33,"phone":23,"phoneExt":23,"email":60},"Mallika Saxena","Mallika.Saxena@ucsf.edu",{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":47,"countryCode":48,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"South Broward Hospital Disctrict D\u002FB\u002FA Memorial Healthcare System","RECRUITING","Hollywood","Florida","33021",{"type":50,"coordinates":68},[69,70],-80.14949,26.0112,{"lat":70,"lon":69},[73,75],{"name":74,"role":33,"phone":23,"phoneExt":23,"email":23},"Houman Khalili",{"name":76,"role":33,"phone":23,"phoneExt":23,"email":77},"Hina Khan","hikhan@mhs.net",{"facility":79,"status":63,"city":80,"state":81,"zip":82,"country":47,"countryCode":48,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"William Beaumont Hospital","Royal Oak","Michigan","48073",{"type":50,"coordinates":84},[85,86],-83.14465,42.48948,{"lat":86,"lon":85},[89,91],{"name":90,"role":33,"phone":23,"phoneExt":23,"email":23},"Amr Abbas",{"name":92,"role":33,"phone":23,"phoneExt":23,"email":93},"Lauren Scribner","Lauren.Scribner@corewellhealth.org",{"facility":95,"status":63,"city":96,"state":97,"zip":98,"country":47,"countryCode":48,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Mayo Clinic","Rochester","Minnesota","55905",{"type":50,"coordinates":100},[101,102],-92.4699,44.02163,{"lat":102,"lon":101},[105,107],{"name":106,"role":33,"phone":23,"phoneExt":23,"email":23},"Mackram F Eleid, M.D.",{"name":108,"role":33,"phone":109,"phoneExt":23,"email":110},"Tricia A","(507) 422-3897","conley.tricia@mayo.edu",{"facility":112,"status":43,"city":113,"state":114,"zip":115,"country":47,"countryCode":48,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"St-Joseph's Health INC","Syracuse","New York","13203",{"type":50,"coordinates":117},[118,119],-76.14742,43.04812,{"lat":119,"lon":118},[122,124],{"name":123,"role":33,"phone":23,"phoneExt":23,"email":23},"Ayman Iskander",{"name":125,"role":33,"phone":23,"phoneExt":23,"email":126},"Laura Mowers","laura.mowers@sjhcardiology.org",{"facility":128,"status":63,"city":129,"state":130,"zip":131,"country":47,"countryCode":48,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"The Christ Hospital Health Network","Cincinnati","Ohio","45219",{"type":50,"coordinates":133},[134,135],-84.51439,39.12711,{"lat":135,"lon":134},[138,140],{"name":139,"role":33,"phone":23,"phoneExt":23,"email":23},"Santiago Garcia, M.D.",{"name":141,"role":33,"phone":142,"phoneExt":23,"email":143},"Susan Reilly","513-585-2165","Susan.Reilly@thechristhospital.com",{"facility":145,"status":63,"city":146,"state":147,"zip":148,"country":149,"countryCode":150,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"IUCPQ","Québec","Quebec","G1V 4G5","Canada","CA",{"type":50,"coordinates":152},[153,154],-71.21454,46.81228,{"lat":154,"lon":153},[157,159,160],{"name":158,"role":33,"phone":34,"phoneExt":23,"email":35},"Josep Rodes-Cabau, MD",{"name":37,"role":33,"phone":34,"phoneExt":38,"email":39},{"name":158,"role":30,"phone":23,"phoneExt":23,"email":23},{"type":30,"investigatorFullName":162,"investigatorTitle":163,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Josep Rodes-Cabau","Principal investigator","100474540","valve-hemodynamic-optimization-based-on-doppler-echocardiography-vs-catheterization-measurements-following-viv-tavr-100474540",false,"NCT05459233","Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR","Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial","ECHOCATH","Inclusion Criteria:\n\n* Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and\u002For regurgitation approved for a valve-in-valve procedure by the Heart Team\n* Surgical stented bioprosthetic valve (label size ≤25 mm)\n* TAVR with the SAPIEN 3 Ultra valve\n\nExclusion Criteria:\n\n* Stentless or sutureless surgical valves\n* Trifecta bioprosthesis\n* Hancock II bioprosthesis\n* High-risk of coronary obstruction (defined either as a virtual transcatheter valve - coronary distance as evaluated by CT \\\u003C4 mm or based on the criterion of the heart team responsible for the procedure).\n* Impossibility to obtain written informed consent","ALL","18 Years",{"count":175,"type":176},310,"ESTIMATED","INTERVENTIONAL",[179],"NA","Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between echocardiography and catheterization, with an overestimation of the real gradient with echo (vs. cath) in most cases. Thus, the incidence of procedural-device failure may be lower than that reported in the ViV-TAVR literature,",[182,183,184],"Aortic Valve Stenosis","Aortic Valve Regurgitation","Prosthesis Failure","2026-03-23",{"date":187,"type":188},"2026-03-24","ACTUAL",{"date":190,"type":188},"2023-01-11",{"date":192,"type":176},"2029-09-01",{"name":5,"class":6},7]