[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tricuspid-atresia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tricuspid-atresia":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"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":53},"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",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":53},"100370678","nirs-in-congenital-heart-defects---correlation-with-echocardiography-100370678","NCT04106479","NIRS in Congenital Heart Defects - Correlation With Echocardiography","Do Cerebral and Renal Saturations Measured With Near-infrared Spectroscopy Correlate With Echocardiographic Markers of Perfusion and Cardiac Performance in Congenital Heart Disease?","Inclusion Criteria:\n\nA prospective study will be conducted of all newborns with tetralogy of fallot, trucus arteriosus, D-transposition of great arteries, PS, AS, coarctation of the aorta, DILV, AVC, DORV, HLHS, TA and PAIVS consecutively admitted at our institution (Montreal Children's Hospital) neonatal intensive care unit (NICU) from January 2018 to January 2020. Patients with CHD will be compared to a control population of term infants admitted and monitored in the NICU with antenatal suspicion of coarctation, ruled-out postnatally.\n\nExclusion Criteria:\n\nPatients will be excluded if premature less than 34 weeks of estimated gestational age (GA) at birth or if parents do not consent. Parental consent can be withdrawn at any time during the study.","0 Days","7 Days",{"count":64,"type":20},100,"OBSERVATIONAL","Neonatal patients with congenital heart defects (CHD) have changing physiology in the context of transitional period. Patients with CHD are at risk of low perfusion status or abnormal pulmonary blood flow. Near infrared spectroscopy has been used in neonatal intensive care units (NICU) to measure end-organ perfusion. The investigator plan on monitoring newborns with CHD admitted to the NICU with NIRS and echocardiography during the first week of life and correlate measures of perfusion from Dopplers to cerebral and renal NIRS.",[68,32,69,70,71,72,73,30,74,75,76],"Congenital Heart Defect","Coarctation of Aorta","Atrioventricular Canal","Hypoplastic Left Heart","Transposition of Great Vessels","Interrupted Aortic Arch","Pulmonary Atresia","Aortic Atresia","Tetralogy of Fallot","2025-06-12",{"date":79,"type":45},"2025-06-17",{"date":81,"type":45},"2019-10-11",{"date":83,"type":20},"2025-12-01",{"name":85,"class":52},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre"]