[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568992":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":29,"locations":38,"responsibleParty":59,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Instituto Dante Pazzanese de Cardiologia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Aortic Valve Replacement - Dafodil Prosthesis","EXPERIMENTAL","Patients indicated for surgical aortic valve replacement will be randomized to receive the Dafodil prosthesis.",[13],"Device: Dafodil prosthesis",{"label":15,"type":16,"description":17,"interventionNames":18},"Aortic Valve Replacement - Inspires Resilia prosthesis","ACTIVE_COMPARATOR","Patients indicated for surgical aortic valve replacement will be randomized to receive Inspires Resilia prosthesis.",[19],"Device: Aortic Valve Replacement - Inspires Resilia prosthesis",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Dafodil prosthesis","Surgical aortic valve replacement (SAVR) will be performed following standardized protocols to ensure consistency and optimize patient outcomes. Under general anesthesia, a median sternotomy will be conducted to access the aorta. Cardiopulmonary bypass (CPB) will be initiated, and the aorta will be cross-clamped to facilitate the safe removal of the existing prosthesis. After excising the deteriorated valve and removing any calcification, the new bioprosthetic valve will be implanted after randomized.",[9],null,{"type":22,"name":15,"description":24,"armGroupLabels":28,"otherNames":26},[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":26,"email":34},"Tacianne Rolemberg Delamain, Master Degree","CONTACT","551150856353","patricia.paiva@dantepazzanese.org.br",{"name":36,"role":32,"phone":33,"phoneExt":26,"email":37},"Kleber Gomes Franchini, PhD","kleber.franchini@dantepazzanese.org.br",[39],{"facility":5,"status":40,"city":41,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","São Paulo","04012909","Brazil","BR",{"type":46,"coordinates":47},"Point",[48,49],-46.63611,-23.5475,{"lat":49,"lon":48},[52,56],{"name":53,"role":32,"phone":54,"phoneExt":26,"email":55},"Tacianne Rolemberg Delamain, Medical doctor","55 11 50856000","taciannebraga@dantepazzanese.org.br",{"name":57,"role":32,"phone":26,"phoneExt":26,"email":58},"Patrícia Paiva","patriciapaiva@dantepazzanese.org.br",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Tacianne Rolemberg Braga Delamain","Cardiologist assistant","100568992","valvular-assessment-of-new-generation-aortic-replacement-devices-100568992",false,"NCT06688448","Valvular Assessment of New Generation Aortic Replacement Devices","Comparative Efficacy and Durability of Next-Generation Biological Aortic Prostheses.","VANGUARD","Inclusion Criteria:\n\n* Age: 18 to 65 years.\n* Eligible for surgical replacement of native valve or re-replacement of a prosthetic valve with a bioprosthetic valve in the aortic position.\n\nExclusion Criteria:\n\n* Indicated for mechanical prosthetic valve replacement.\n* Require surgical intervention in another heart valve or transcatheter valve therapy.","ALL","18 Years","65 Years",{"count":75,"type":76},200,"ESTIMATED","INTERVENTIONAL",[79],"NA","The VANGUARD study is an open-label, prospective, randomized trial comparing the long-term outcomes of two advanced bioprosthetic aortic valves, Dafodil® and INSPIRIS Resilia®, in patients undergoing aortic valve replacement (AVR). This study aims to provide robust data on valve durability, safety, and hemodynamic performance, particularly in younger patients who may require multiple interventions over their lifetimes.",[82,83,84],"Aortic Regurgitation Disease","Aortic Valve Calcification","Bicuspid Aortic Valve Disease",[86,87,88,89,90],"aortic valve surgery","Dafodil®","Inspires Resilia®","bioprosthetic valves","aortic valve replacement","2025-01-09",{"date":93,"type":94},"2025-01-13","ACTUAL",{"date":96,"type":94},"2024-12-01",{"date":98,"type":76},"2036-12-01",{"name":5,"class":6},1]