[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546851":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":45,"locations":24,"responsibleParty":55,"collaborators":24,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":24,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":24,"overallStatus":79,"whyStopped":24,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":24},{"fullName":5,"class":6},"Medstar Health Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TAVR-explant","ACTIVE_COMPARATOR","TAVR surgical explantation",[13],"Procedure: TAVR-explant",{"label":15,"type":10,"description":16,"interventionNames":17},"Redo-TAVR","TAV-in-TAV",[18],"Device: Redo-TAVR",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Surgical explantation of failed THV followed by surgical aortic valve replacement and any other cardiac surgeries deemed necessary.",[9],null,{"type":26,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","Repeat transcatheter aortic valve implantation within a failed THV.",[15],[30],"Valve-in-Valve, TAV-in-TAV",[32,36,39,41,43],{"name":33,"affiliation":34,"role":35},"Ron Waksman, MD","MedStar Health Research Organization","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":34,"role":38},"Toby Rogers, MD","STUDY_CHAIR",{"name":40,"affiliation":34,"role":38},"Thomas MacGillivray, MD",{"name":42,"affiliation":34,"role":38},"Michael Reardon, MD",{"name":44,"affiliation":34,"role":38},"Kalyan Chitturi, DO",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":24,"email":50},"Kassandra Lopez","CONTACT","202-877-2452","kassandra.lopez@medstar.net",{"name":52,"role":48,"phone":53,"phoneExt":24,"email":54},"Jake Sutton","202-877-6624","Joseph.A.Sutton@medstar.net",{"type":56,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100546851","randomized-evaluation-for-failed-tavr-100546851",false,"NCT06400342","Randomized Evaluation for Failed TAVR","Randomized Evaluation of Valve-In-Valve Versus Explantation for Failed TAVR (REVIVE-TAVR)","REVIVE-TAVR","Inclusion Criteria:\n\n* Heart Team has confirmed eligibility for both TAVR-explant and redo-TAVR for failed THV\n* Subject is symptomatic from their failed THV, as demonstrated by NYHA Functional Class ≥II\n* Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits\n* Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.\n\nExclusion Criteria:\n\n* Ongoing sepsis, including active endocarditis;\n* Severe dementia (resulting in either inability to provide informed consent for the trial\u002Fprocedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);\n* Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams;\n* Pregnancy or intent to become pregnant for the next 12 months;\n\nCoronary obstruction risk:\n\n\\- Patients at risk of coronary obstruction may be enrolled into the randomized cohort if the operators determine that redo-TAVR can be safely accomplished with leaflet modification or other coronary protection strategies.","ALL","18 Years","100 Years",{"count":69,"type":70},264,"ESTIMATED","INTERVENTIONAL",[73],"NA","REVIVE TAVR is an acronym for the Randomized Evaluation of Valve-In-Valve versus Explantation for failed TAVR. This is a prospective, multicenter, global randomized trial investigating the safety and efficacy of reintervention for transcatheter heart valve (THV) failure by comparing redo-TAVR (TAV-in-TAV) with TAVR surgical explantation (TAVR-explant) in subjects who are suitable for both options in a real-world clinical setting",[76,77,78],"Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure","Prosthetic Valve Malfunction","Prosthesis Failure","NOT_YET_RECRUITING","2025-01-21",{"date":82,"type":83},"2025-01-24","ACTUAL",{"date":85,"type":70},"2025-03-01",{"date":87,"type":70},"2036-05-01",{"name":5,"class":6}]