[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unbalanced-av-canal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unbalanced-av-canal":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":37,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":5},"100398402","phase-2-two-year-study-of-the-safety-and-efficacy-of-the-second-generation-tissue-engineered-vascular-grafts-100398402",false,"NCT04467671","Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts","Prospective, Open-labeled, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of the Second-generation Tissue Engineered Vascular Graft as Vascular Conduits for Extracardiac Total Cavopulmonary Connection.","TEVG-2","Inclusion Criteria:\n\n* Patients will be eligible for inclusion in the study if they meet all of the following criteria.\n\n  1. Patient must be a candidate to undergo an extracardiac total cavopulmonary connection.\n  2. Patient and\u002For legal guardian must voluntarily provide informed consent\u002Fassent for participation in the study.\n\nExclusion Criteria:\n\n* Patients will be excluded from participation in the study if they meet any of the following criteria.\n\n  1. Patient has an urgent\u002Femergent operative status.\n  2. Patient has acute renal failure or renal insufficiency in the opinion of the investigator\n  3. Patient requires a graft less than 12 mm or greater than 24 mm in diameter.\n  4. Patient has a pacemaker.\n  5. Patient has pulmonary vascular resistance greater than 4 um2 (u=Wood's units)\n  6. Patient has abnormal venous drainage (interrupted inferior vena cava \\[IVC\\]).\n  7. Patient presents with significant atrio-ventricular valve regurgitation that in the opinion of the investigator, makes them ineligible.\n  8. Patient has a history of another condition or significant medical problem that, in the opinion of the investigator, precludes compliance with protocol-specified procedures.\n  9. Patients taking any medications that in the opinion of the Investigator could interfere with the TEVG, including bisphosphonates (i.e. Clodronate or Zoledronate).\n  10. Patient or parent\u002Flegal guardian is, in the opinion of the investigator, unable to comply with protocol evaluations.\n  11. Preoperative hemoglobin \\\u003C11.0 mg\u002FdL at time of patient's pre-admission testing.","ALL",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.",[26,27,28,29,30,31,32,33,34,35,36],"HLH - Hypoplastic Left Heart Syndrome","DORV","DILV - Double Inlet Left Ventricle","Mitral Atresia","Tricuspid Atresia","Unbalanced AV Canal","Single-ventricle","Heart Defects, Congenital","Cardiovascular Abnormalities","Cardiovascular Diseases","Heart Diseases",[38,39,40],"Fontan","TEVG","Tissue Engineered Vascular Graft","RECRUITING","2025-06-24",{"date":44,"type":45},"2025-06-27","ACTUAL",{"date":47,"type":45},"2020-07-15",{"date":49,"type":20},"2027-08",{"name":51,"class":52},"Nationwide Children's Hospital","OTHER"]