[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545863":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":45,"collaborators":20,"id":48,"slug":20,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":20,"eligibilityCriteria":52,"healthyVolunteers":49,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":20,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":20,"overallStatus":32,"whyStopped":20,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Valve transplantation group","EXPERIMENTAL","This arm undergoes Allogeneic Valve transplantation",[13],"Procedure: Valve transplant",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Valve transplant","Heart valves from an organ donor will be transplanted into recipient",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Sitaram Emani, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","6173557899","sitaram.emani@cardio.chboston.org",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Boston","Massachusetts","02115","United States",{"type":38,"coordinates":39},"Point",[40,41],-71.05977,42.35843,{"lat":41,"lon":40},[44],{"name":23,"role":27,"phone":20,"phoneExt":20,"email":20},{"type":24,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Sitaram Emani","Associate Professor of Surgery","100545863",false,"NCT06387446","Allogeneic Valve Transplantation","Inclusion Criteria\n\n* Patients requiring aortic, pulmonary, mitral or tricuspid valve replacement.\n* Pediatric patients 30 days or older and \\\u003C 18 years, and adult patients 18-50 yrs.\n\n  o Particularly patients with significant growth potential\n* Insufficient options are available for valve replacement\n\n  o Patients at risk of immunogenic bio-prosthetic valve failure\n* Discussion with patient \u002Ffamily - option for durable valve rather than traditional prosthesis\n* ABO compatible\n* Patient and family able to travel to BCH within 48 hour time frame or within our organ procurement organization\n* Patients that are able to maintain follow-up at BCH during the duration of the study\n* Patients that are able to provide medical record authorization for 5 year follow-up\n\nExclusion Criteria\n\n* Age \\\u003C 30 days\n* Irreversible multisystem organ failure; or additive effects of the multiple systems affected making transplant survival unlikely\n* Progressive systemic disease with early mortality (genetic\u002Fmetabolic, idiopathic, syndromic)\n* Morbid obesity (BMI\\>35)\n* Diabetes mellitus with evidence of end-organ damage\n* Severe chromosomal, neurologic or syndromic abnormalities\n* Immunocompromised condition (DiGeorge, SCID etc.)\n* Active infection\n* History of endocarditis\n* HIV or chronic hepatitis B or C infection\n* Malignancy within 5 years prior to transplant\n* Severe renal or liver failure\n* Inadequate social support for post-transplant management\n* Recent history of illicit drug, tobacco or alcohol abuse despite trials\u002Fassistance to stop behavior\n* Evidence of large stroke with high risk for hemorrhagic conversion\n* Heart transplant recipient\n* Patients that are unable to follow-up during the initial 6 month window\n* Patients that are unable to provide medical record authorization for 5 years","ALL","30 Days","50 Years",{"count":57,"type":58},4,"ESTIMATED","INTERVENTIONAL",[61],"NA","Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.",[64,65,66],"Valve Heart Disease","Valve Disease, Heart","Valve Disease, Aortic","2024-09-22",{"date":69,"type":70},"2024-09-24","ACTUAL",{"date":72,"type":70},"2024-05-01",{"date":74,"type":58},"2027-06-01",{"name":5,"class":6},1]