[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transposition-of-great-vessels\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transposition-of-great-vessels":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,80,113],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100370678","nirs-in-congenital-heart-defects---correlation-with-echocardiography-100370678",false,"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 Parental consent can be withdrawn at any time during the study.","ALL","0 Days","7 Days",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","Neonatal patients with congenital heart defects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.",[25,26,27,28,29,30,31,32,33,34,35],"Congenital Heart Defect","Single-ventricle","Coarctation of Aorta","Atrioventricular Canal","Hypoplastic Left Heart","Transposition of Great Vessels","Interrupted Aortic Arch","Tricuspid Atresia","Pulmonary Atresia","Aortic Atresia","Tetralogy of Fallot","RECRUITING","2025-06-12",{"date":39,"type":40},"2025-06-17","ACTUAL",{"date":42,"type":40},"2019-10-11",{"date":44,"type":21},"2025-12-01",{"name":46,"class":47},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":69,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":5},"100501442","effects-branch-pa-stenting-d-tga-tof-and-ta-100501442","NCT05809310","Effects Branch PA Stenting d-TGA, ToF and TA","The Effects of Branch Pulmonary Artery Stenting in d-TGA, ToF and TA: a Randomized Control Trial","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Patients with d-TGA post ASO, ToF or TA\n* ≥8 years\n\nExclusion Criteria:\n\nOne or more of the following inclusion criteria:\n\n* All class IIa indications for a branch PA intervention:\n* Persistent decreased RV function (based on gold standard CMR)\n\n  * \\\u003C18 years RVEF ≤55% (28)\n  * ≥18 years RVEF\\\u003C50% (29)\n* Progressive tricuspid regurgitation (TR) (≥moderate)\n* Isolated bifurcation stenosis:\n\n  * Significant unilateral stenosis (≥50%)\n  * Borderline bilateral PA stenosis (40-70%)\n* Unbalanced perfusion (≤35\u002F65%)\n* RV\u002FLV pressure ratio \\> 2\u002F3 based on echocardiography\n* Reduced lung perfusion or decreased objective exercise capacity (based of gold standard VO2 max during CPET)\n\n  * \\\u003C18 years VO2 peak \\\u003C35 mL∙kg-1∙min-1 (boys) VO2 peak \\\u003C30 mL∙kg-1∙min-1 (girls) (30)\n  * ≥18 years VO2 peak \\\u003C27 mL∙kg-1∙min-1 (men) VO2 peak \\\u003C19 mL∙kg-1∙min-1 (women) (31)","8 Years",{"count":58,"type":21},56,"INTERVENTIONAL",[61],"NA","The goal of this randomized controlled trial is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA.\n\nThe main question\\[s\\] it aims to answer are:\n\nThe primary study objective is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The secondary objectives are 1) to assess the effects of percutaneous interventions for branch PA stenosis on RV function and 2) to define early markers for RV function and adaptation to improve timing of these interventions.\n\nParticipants will undergo the same series of examinations at baseline and approximately 6 months follow-up (within 6 week time-range) as part of standard care: conventional transthoracic echocardiogram (TTE), cardiopulmonary exercise testing (CPET) and conventional Cardiac Magnetic Resonance (CMR) including a low dose dobutamine stress MRI to assess RV functional reserve. The low dose dobutamine stress MRI will be performed in the interventional group from the UMC Utrecht\u002FWKZ and Erasmus MC because the LUMC and AUMC do not have a suitable infrastructure for the low dose dobutamine stress MRI and this cannot be achieved throughout the duration of this study. The baseline CMR in the interventional group will be performed as close as possible prior to the intervention but maximal 4 weeks prior to the intervention. In addition, the intervention group will undergo standard RV pressure measurements during the intervention. Quality of life (QoL) questionnaires will be obtained at baseline and 2 weeks post intervention (intervention group) or a similar time range in the control group, which is based on experts opinion. TTE, CPET and conventional CMR will be performed within 2-4 years follow-up to assess the long-term effects of percutaneous PA interventions.\n\nResearchers will compare the difference in VO2 max (% predicted) between the interventional group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo a percutaneous intervention for a PA stenosis) and the control group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo conservative management)",[30,35,64,65,66,67,68],"Truncus Arteriosus","Pulmonary Artery Stenosis Supravalvular Congenital","Stent Stenosis","Right Ventricular Dysfunction","Congenital Heart Disease",[70],"Exercise capacity","2025-03-25",{"date":73,"type":40},"2025-03-30",{"date":75,"type":40},"2023-04-18",{"date":77,"type":21},"2027-12-31",{"name":79,"class":47},"UMC Utrecht",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":59,"phases":91,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":112},"100474040","masa-valve-early-feasibility-study-100474040","NCT05452720","MASA Valve Early Feasibility Study","MVEFS","Inclusion Criteria:\n\n1. At least one of the following: Right Ventricular to Pulmonary Artery mean gradient \\> 35mm Hg, moderate or severe Pulmonary regurgitation (≥3+), or clinical indication for replacement of their native or prosthetic pulmonary valve with a prosthesis.\n2. Age \\\u003C 22 years\n3. Patient is geographically stable and willing to return for 1 year follow-up for the trial.\n4. Patient's legal guardian should be willing to provide informed consent (IC) at the hospital location where they are being enrolled.\n5. The patient, and the patient's parent \u002F legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits.\n\nExclusion Criteria:\n\n1. Patient is in need of or has presence of a prosthetic heart valve at any other position\n2. Patient has a need for concomitant surgical procedures (non-cardiac)\n3. Patients with previously implanted pacemaker (including defibrillators) or mechanical valves\n4. Patient has an active bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics)\n5. Patient has an active endocarditis\n6. Leukopenia, according to local laboratory evaluation of white blood cell count\n7. Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria\n8. Thrombocytopenia, defined as Platelet count \\\u003C 150,000\u002Fmm3 Patients can be transfused to meet eligibility criteria\n9. Severe chest wall deformity, which would preclude placement of the PV conduit\n10. Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials\n11. Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs\n12. Patient has chronic inflammatory \u002F autoimmune disease\n13. Need for emergency cardiac or vascular surgery or intervention\n14. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year\n15. Currently participating, or participated within the last 30 days, in an investigational drug or device study\n16. Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months\n17. Patient has medical, social or psychosocial factors that, in the opinion of the Investigator, could have impact on safety or compliance","0 Years","22 Years",{"count":90,"type":21},10,[61],"The MASA Valve Early Feasibility Study (MVEFS) multi-site interventional clinical trial within the United States of America with each center following a common protocol.The objective of the trial is to evaluate the safety and probable benefit of MASA Valve in the indicated subset of patients requiring Right Ventricular Outflow Tract Reconstruction (RVOTR). As an early feasibility study, the purpose is determine the feasibility of success of the device in order to gather early data towards a future pivotal study and\u002For regulatory clearance submission.",[94,95,64,30,33,96],"Tetrology of Fallot","Pulmonary Stenosis","Ross Procedure",[98,99,100,101],"Right Ventricular Outflow Tract Reconstruction","Pulmonary Valve","MASA Valve","Pulmonary Valve Replacement","2024-11-04",{"date":104,"type":40},"2024-11-06",{"date":106,"type":40},"2023-05-18",{"date":108,"type":21},"2028-04-01",{"name":110,"class":111},"PECA Labs","INDUSTRY",5,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":125,"studyType":22,"phases":4,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":48},"100384660","canadian-adult-congenital-heart-disease-intervention-registry-100384660","NCT04288596","Canadian Adult Congenital Heart Disease Intervention Registry","The Canadian Registry for Adults With Congenital Heart Disease Interventions","C-ACHDiR","Inclusion Criteria:\n\n* participants must be 18 years or older referred for intervention for one of five ACHD conditions including diagnostic catheterization for complex ACHD patients (Tetralogy of Fallot, Fontan, and transposition of the great vessels, single ventricle, truncus arteriosus); transcatheter closure of atrial septal defects; transcatheter closure of patent foramen ovale; coarctation of aorta stenting, and percutaneous pulmonary valve implantation.\n\nExclusion Criteria:\n\n* participants below the age of 18\n* participants residing outside of Canada","18 Years","110 Years",{"count":124,"type":21},9000,"10 Years","The ACHDi Registry study will create a foundational database for adult congenital heart disease interventions. This Pan-Canadian Registry will collect clinical and patient-reported information that will enable the evaluation of care processes and outcomes in five most common ACHDi interventions by enabling prospective and retrospective registry-based studies to answer important clinical practice and policy-relevant questions.",[128,129,35,130,27,30,131],"Atrial Septal Defect","Patent Foramen Ovale","Fontan","Percutaneous Pulmonary Valve Implantation","NOT_YET_RECRUITING","2020-02-27",{"date":135,"type":40},"2020-02-28",{"date":137,"type":21},"2020-04-01",{"date":139,"type":21},"2030-04-01",{"name":141,"class":47},"University Health Network, Toronto"]