[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100285948":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":26,"locations":32,"responsibleParty":53,"collaborators":10,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":10,"eligibilityCriteria":60,"healthyVolunteers":57,"sex":61,"minAge":62,"maxAge":10,"enrollmentInfo":63,"targetDuration":10,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":10,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Medstar Health Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TAVR",null,"This observational study will enroll subjects that underwent TAVR more than 3 years ago.",[13],"Device: TAVR",{"label":15,"type":10,"description":16,"interventionNames":17},"SAVR","Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago",[18],"Device: SAVR",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","subjects that underwent TAVR more than 3 years ago",[9],{"type":21,"name":15,"description":16,"armGroupLabels":25,"otherNames":10},[15],[27],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Megan Rowland, MPH","CONTACT","202-877-2959","megan.e.rowland@medstar.net",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Washington Hospital Center","RECRUITING","Washington D.C.","District of Columbia","20010","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-77.03637,38.89511,{"lat":45,"lon":44},[48,50],{"name":49,"role":29,"phone":30,"phoneExt":10,"email":31},"Megan Rowland",{"name":51,"role":52,"phone":10,"phoneExt":10,"email":10},"Ron Waksman, MD","PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100285948","transcatheter-aortic-prosthesis-function-a-long-term-follow-up-study-100285948",false,"NCT03002272","Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study","Inclusion criteria for TAVR subjects\n\na) TAVR performed more than 3 years ago\n\nExclusion criteria\n\n1. Subjects unable to consent to participate, unless the subject has a legally authorized representative\n2. Subjects unwilling to participate\n3. Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure)\n4. Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-TAVR (mean aortic gradient ≥20mmHg AND\u002FOR moderate-severe transvalvular aortic regurgitation)\n\nInclusion criteria for SAVR subjects\n\n1. SAVR performed more than 3 years ago\n2. Propensity matched to an enrolled TAVR subject\n\nExclusion criteria for SAVR subjects e) Subjects unable to consent to participate, unless the subject has a legally authorized representative f) Subjects unwilling to participate g) Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure) h) Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-SAVR (mean aortic gradient ≥20mmHg AND\u002FOR moderate-severe transvalvular aortic regurgitation)","ALL","18 Years",{"count":64,"type":65},100,"ESTIMATED","OBSERVATIONAL","In this observational study, the investigators will enroll subjects who underwent TAVR or SAVR more than 3 years ago. Clinical and procedural data from the implant\u002Fsurgery will be collected, alongside clinical and echocardiographic data from subsequent follow-up visits.",[69],"Aortic Valve Replacement","2023-05-25",{"date":72,"type":73},"2023-05-26","ACTUAL",{"date":75,"type":73},"2018-02-20",{"date":77,"type":65},"2028-01",{"name":5,"class":6},1]