[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"single-ventricle\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:single-ventricle":144},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,40,72,103,127,173,210,235,254,286,310,344,373,404],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100599691","impact-of-early-fortini-initiation-on-growth-and-interstage-outcomes-in-infants-with-single-ventricle-physiology-100599691",false,"NCT07087782","Impact of Early Fortini Initiation on Growth and Interstage Outcomes in Infants With Single Ventricle Physiology","Inclusion Criteria:\n\n1. Infants with single ventricle physiology who have undergone Stage 1 surgical palliation (e.g., Norwood, hybrid, or BT shunt)\n2. Medically stable and ready for discharge from the hospital\n3. Feeding via oral, nasogastric (NG), or gastrostomy tube\n4. Age \\\u003C or = 6 months at time of discharge\n5. Parent or legal guardian able to provide informed consent\n\nExclusion Criteria:\n\n1. Preexisting gastrointestinal condition contraindicating formula use (e.g. NEC, short gut, malabsorption)\n2. Contraindication to Fortini (e.g. proven cow's milk protein allergy)\n3. Current enrollment in another interventional feeding or nutrition study\n4. Social circumstances likely to preclude safe outpatient follow up","ALL","0 Months","6 Months",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study is testing whether a special formula called Fortini, which is a high-calorie, low osmolality formula can help high-risk babies with single ventricle physiology grow better after their initial Stage 1 surgical palliation. These babies often struggle to gain weight, which can lead to more health problems before their next surgery.\n\nAfter their first heart surgery, but prior to discharge, babies will be randomly placed into two groups. One group will get Fortini formula when they leave the hospital, and the other group will get the standard of care high-calorie formula. The primary goal is to see if Fortini helps babies grow better by the time they are ready for their second surgery.\n\nThe study will also check if the babies tolerate the formula well, how much they eat, how often they are re-admitted to the hospital, and how their caregivers feel about feeding. The babies will be followed for up to 4 months, until they return for their next surgery. About 100 infants are expected to join the study at Driscoll Children's Hospital.\n\nThis research may help improve nutrition care for infants with complex heart conditions and reduce stress for their families.",[26],"Single-ventricle","RECRUITING","2026-05-11",{"date":30,"type":31},"2026-05-13","ACTUAL",{"date":33,"type":31},"2025-07-30",{"date":35,"type":20},"2029-06",{"name":37,"class":38},"Driscoll Children's Hospital","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":15,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100609872","venous-compression-in-fontan-100609872","NCT07220226","Venous Compression in Fontan","Venous Function and the Effect of Venous Compression on Exercise Cardiovascular Function in Patients With Fontan Circulation.","Patients with a Fontan circulation -\n\nInclusion criteria:\n\n• Patients at UTSW aged 18-45 years old with a Fontan circulation.\n\nExclusion Criteria:\n\n* NYHA Class 4\n* Severe AV valve regurgitation\n* Severe ventricular dysfunction\n* Large ascites\n* Significant varicosities\n* Atrio-pulmonary (AP) Fontan\n* Known Fontan thrombus\n* Poorly controlled arrythmia\n* Unplanned cardiac admission in the last 6 months\n* Cyanosis (resting O2 saturation \\\u003C85%)\n* Pregnant\n* Common femoral vein obstruction \\>50% to be performed following completion of informed consent.\n\nHealthy Controls:\n\nHealthy control participants will be recruited on the basis of having no known chronic diseases and not currently taking any cardiovascular medications.",true,"18 Years","45 Years",{"count":51,"type":20},20,[23],"The aim of this study is to investigate whether venous compression garments increase exercise stroke volume in patients with Fontan circulation. To address this aim, we will test the following hypotheses:\n\n1. Acute and chronic external venous compression will increase exercise stroke volume in patients with Fontan circulation.\n2. Patients with significant venous varicosities will have a greater response to venous compression.\n\nParticipants will:\n\n* Undergo submaximal exercise testing in MRI to measure venous return and exercise stroke volume with and without the wearing of compression garments\n* Undergo submaximal exercise testing on a seated upright exercise ergometer with concurrent measurement of stroke volume with and without the wearing of compression garments\n* A subset of participants will repeat both testing visits after wearing compression garments for 2-weeks during waking hours.\n\nParticipants will:\n\n* Undergo submaximal exercise testing in MRI to measure venous return and exercise stroke volume with and without the wearing of compression garments\n* Undergo submaximal exercise testing on a seated upright exercise ergometer with concurrent measurement of stroke volume with and without the wearing of compression garments\n* A subset of participants will repeat both testing visits after wearing compression garments for 2-weeks during waking hours.",[26,55],"Fontan Circulation",[57,58,59,55,60,61],"Venous Compression","Exercise Testing","Cardiac Reserve","Magnetic Resonance Imaging","vascular function","NOT_YET_RECRUITING","2026-04-18",{"date":65,"type":31},"2026-04-22",{"date":67,"type":20},"2026-05-10",{"date":69,"type":20},"2027-11-01",{"name":71,"class":38},"University of Texas Southwestern Medical Center",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":15,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":39},"100586701","fontan-fitness-trial-100586701","NCT06918795","Fontan Fitness Trial","Home-based, Digital Intervention to Increase Physical Activity in Patients With the Fontan Circulation","Inclusion Criteria:\n\n* Fontan Circulation present\n* Girls ≥11 years of age or menstruating must have negative urine pregnancy test\n* Neurodevelopmental capacity to complete all study procedures\n* Physical capacity to complete all study procedures\n* English speaking with at least one English speaking parent\u002Fguardian\n* To enroll in the randomized control trial, percent predicted peak VO2 \\\u003C80% of age-sex matched normal controls on the baseline exercise stress test (EST)\n\nExclusion Criteria:\n\n* Inability to complete an EST at any time (i.e. limited physical or executive function)\n* Uncontrolled lymphatic disorders\n* Uncontrolled noncardiac conditions\n* Exercise induced or uncontrolled arrhythmias\n* Pacemaker or internal cardiac defibrillator (ICD)\n* Peak VO2 \\\u003C45% age-sex predicted\n* Having had or under consideration for a heart transplant\n* Pregnant or lactating females\n* Parents\u002Fguardians or subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures","10 Years","17 Years",{"count":82,"type":20},200,[23],"The goal of this randomized control trial is to learn about physical fitness and exercise habits in children aged 10-17 with the Fontan Circulation through a home-based, digital exercise intervention. The main questions it aims to answer are:\n\n* Does a home-based, digital intervention increase physical activity (PA) in youth with the FC compared to enhanced usual care?\n* Does a home-based, digital intervention increase physical fitness in youth with the FC compared to enhanced usual care?\n* Do multi-level factors (medical, neurodevelopmental, sociodemographic, neighborhood) impact the effectiveness of the digital intervention?\n\nResearchers will compare participants in the enhanced usual care arm to those in the exercise intervention arm to see if the digital intervention is effective.\n\nAll participants will wear a PA tracker for 12 months and complete testing at baseline, 6 months, and 12 months.\n\nIn addition, participants in the exercise intervention arm will complete a 6-month exercise intervention with the following components:\n\n* aerobic exercise\n* resistance exercise\n* engagement strategies",[26,86],"Congenital Heart Disease",[88,89,90,91,92,93],"Fontan","Single ventricle disease","exercise intervention","digital health","adolescents","randomized control trial","2026-04-07",{"date":96,"type":31},"2026-04-13",{"date":98,"type":31},"2025-06-09",{"date":100,"type":20},"2029-04",{"name":102,"class":38},"Children's Hospital of Philadelphia",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":39},"100549452","extracellular-vesicle-micro-rna-profiling-in-congenital-heart-disease-fetal-maternal-regulation-in-neonatal-thrombosis-100549452","NCT06434207","Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis","EVmiRNA","Inclusion Criteria:\n\n* All neonates with a diagnosis of severe Congenital Heart Disease undergoing surgery at Boston Children's Hospital in the first week of life\n\nExclusion Criteria:\n\n* None","1 Day","7 Days",{"count":113,"type":20},10,"OBSERVATIONAL","Newborns with congenital heart disease (CHD) are at increased risk of developing postpartum and postoperative blood clots after cardiac surgery. The molecular mechanisms that are responsible for the clotting profile predisposing children to blood clots in the early stages of life are currently not well described.\n\nThe goal of this proposal is to prospectively collect plasma samples from ten (10) neonates with antenatal diagnosis of severe congenital heart disease (CHD) to better understand mechanisms responsible for abnormal clotting in the perioperative period.",[86,26,117],"Thrombosis","2026-02-20",{"date":120,"type":31},"2026-02-23",{"date":122,"type":31},"2024-10-31",{"date":124,"type":20},"2026-12-01",{"name":126,"class":38},"Boston Children's Hospital",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":4,"enrollmentInfo":135,"targetDuration":137,"studyType":114,"phases":4,"briefSummary":138,"conditions":139,"keywords":146,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"100587722","adult-congenital-heart-disease-international-evaluation-of-the-effectiveness-of-sglt2i-registry-100587722","NCT06932081","Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry","Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i (ACHIEVE-SGLT2i) Registry","ACHIEVE-SGLT2i","Inclusion Criteria:\n\n* Congenital heart defect.\n* Age ≥ 18 years.\n* Initiated on treatment with an SGLT2i.\n\nExclusion Criteria:\n\n\\- No consent for data collection.",{"count":136,"type":20},400,"1 Year","This real-world, international registry aims to evaluate the current experience with sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adult congenital heart disease (ACHD) patients by investigating the prescription patterns, safety, tolerability, and potential beneficial effects on heart failure-related outcomes.",[140,86,141,142,143,88,144,145],"Adult Congenital Heart Disease","Systemic Right Ventricle","Transposition of the Great Arteries","Congenitally Corrected Transposition of the Great Arteries","Single Ventricle","Tetralogy of Fallot (TOF)",[147,148,149,150,151,152,153,154,155,156,157,158,159,88,160,161,162],"adult congenital heart disease","ACHD","congenital heart disease","CHD","sodium-glucose cotransporter 2 inhibitors","SGLT2i","SGLT2","heart failure","HF","transposition of the great arteries","TGA","systemic right ventricle","sRV","single ventricle","tetralogy of fallot","ToF","2026-02-11",{"date":165,"type":31},"2026-02-13",{"date":167,"type":31},"2023-01-01",{"date":169,"type":20},"2027-12-31",{"name":171,"class":38},"Leiden University Medical Center",11,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":15,"minAge":181,"maxAge":17,"enrollmentInfo":182,"targetDuration":4,"studyType":21,"phases":183,"briefSummary":186,"conditions":187,"keywords":191,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":209},"100563231","phase-1-pkpd-of-digoxin-in-infants-with-svhd-100563231","NCT06613477","PK\u002FPD of Digoxin in Infants With SVHD","Pharmacokinetics and Pharmacodynamics of Digoxin in Infants With Single Ventricle Heart Disease","Digoxin R01","Inclusion Criteria:\n\n1. Diagnosis of single ventricle congenital heart disease\n2. Status post-surgical or hybrid stage 1 palliation but prior to surgical stage 2 palliation\n3. Age ≤ 30 days of life at time of stage 1 palliation\n4. Age \\\u003C 6 months at time of enrollment\n5. Require treatment with enteral digoxin per their treating medical provider\n6. Informed consent obtained from parent(s) or legal guardian(s)\n\nExclusion Criteria:\n\n1. Gestational age at birth \\\u003C35 weeks\n2. Serum creatinine \\> 2 mg\u002FdL at enrollment\n3. Diagnosis of second degree or higher atrioventricular conduction block at enrollment\n4. Diagnosis of clinically significant sinus bradycardia requiring intervention at enrollment\n5. Known hypersensitivity to digoxin or other forms of digitalis\n6. Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device) at enrollment\n7. Received digoxin prior to enrollment\n8. Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study","30 Days",{"count":51,"type":20},[184,185],"PHASE1","PHASE2","The primary participant will be an infant with single ventricle heart disease.\n\nThis is a research study to learn more about how the medication digoxin, which is routinely prescribed to infants and children with heart disease in pediatric cardiac intensive care units is processed by their bodies and how it may help their cardiac function.\n\nThe investigators will collect blood or will collect blood samples when bloodwork is checked as part of regular care (\"opportunistic\"). The investigators will also collect information from medical records.\n\nBeing part of this study will not change treatment plan or medications. The risks of this study include loss of confidentiality and risks associated with having blood drawn. The study team will make every effort to minimize these risks.",[26,188,189,190],"Infant Conditions","Infant, Newborn, Diseases","Infant, Premature, Diseases",[192,193,194,144,195,196,197,198,199],"Infants","SVD","SVHD","Digoxin","Pharmacokinetics","Pharmacodynamics","PK","PD","2026-01-28",{"date":202,"type":31},"2026-01-30",{"date":204,"type":31},"2024-10-10",{"date":206,"type":20},"2026-11-30",{"name":208,"class":38},"Duke University",2,{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":21,"phases":219,"briefSummary":220,"conditions":221,"keywords":223,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":209},"100527683","rehab-fontan-failure-a-trial-of-cardiac-rehabilitation-100527683","NCT06150950","REHAB Fontan Failure: A Trial of Cardiac Rehabilitation","RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure","Inclusion Criteria:\n\n* Fontan failure, defined as history of a Fontan procedure and at least one of the following: systemic ventricular EF \\\u003C50% (by echocardiography, cardiac magnetic resonance imaging, or computer tomography), protein losing enteropathy, plastic bronchitis, chronic loop diuretics prescribed by ACHD Cardiologist, and\u002For peak VO2 \\\u003C 50% predicted (by FRIEND equation)\n* Age \\>= 18 years old\n\nExclusion Criteria:\n\n* Inotrope-dependence\n* Symptomatic, uncontrolled arrhythmias\n* Pregnancy\n* Contraindication to cardiac rehab or already enrolled in cardiac rehabilitation\n* Inability to comply with the protocol\n* Recent (\\\u003C3 months) planned Fontan pathway percutaneous or surgical intervention\n* Resting hypoxemia with baseline oxygen saturation \\\u003C80%",{"count":218,"type":20},50,[23],"The goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life.\n\n1. Among patients with Fontan failure, will cardiac rehabilitation increase average daily steps compared to usual care?\n2. Among patients with Fontan failure, will cardiac rehabilitation improve exertional tolerance (as measured by cardiopulmonary exercise testing), frailty, and self-reported quality of life metrics compared to usual care?",[222,26],"Heart Failure Congenital",[88,224,225],"Single ventricle","Cardiac rehabilitation","2025-12-31",{"date":228,"type":31},"2026-01-05",{"date":230,"type":31},"2024-05-05",{"date":232,"type":20},"2026-12-31",{"name":234,"class":38},"Stanford University",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":21,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":39},"100459460","ventripoint-single-ventricle-study-100459460","NCT05262907","Ventripoint Single Ventricle Study","Assessment of Ventricular Volumes and Function in Single Ventricle Patients Using Ventripoint 3D Echocardiography","Inclusion Criteria:\n\n* All patients with functional single ventricles will be included, regardless of age or surgical palliation stage, who have had or are having a clinically ordered transthoracic echocardiogram and\u002For cardiac MRI.\n\nExclusion Criteria:\n\n* Patients with congenital heart disease other than functional single ventricles, patients with single ventricle physiology (but not single ventricle anatomy) following a biventricular conversion pathway, or patients unable to understand or consent in English will be excluded.",{"count":19,"type":20},[23],"This study will validate a coordinate-based 3-dimensional echocardiographic technique for the assessment of cardiac size and function in children and young adults with functional single ventricles.",[86,26],"2025-10-21",{"date":248,"type":31},"2025-10-23",{"date":250,"type":31},"2022-07-08",{"date":252,"type":20},"2027-08",{"name":208,"class":38},{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":15,"minAge":262,"maxAge":263,"enrollmentInfo":264,"targetDuration":4,"studyType":21,"phases":266,"briefSummary":268,"conditions":269,"keywords":271,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":285},"100269053","phase-3-cardiac-stemprogenitor-cell-infusion-in-univentricular-physiology-apollon-trial-100269053","NCT02781922","Cardiac Stem\u002FProgenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)","Efficacy and Safety Study of Autologous Cardiac Stem Cells (JRM-001) Treated After Reconstructive Surgery in Pediatric Patients With Congenital Heart Disease: A Multicenter Randomized Single-blind Parallel-group Study","APOLLON","Inclusion Criteria:\n\n* Functional single ventricle patient with heart failure who is scheduled for stage 2 (Glenn) or stage 3 (Fontan) surgery\n* EF(%) by echocardiography ≤ 55%\n* Able to obtain written informed consent of participation in the study by a parent of the patient\n\nExclusion Criteria:\n\n* Known medical history of cardiogenic shock\n* Lethal, uncontrollable arrhythmia\n* Complication of coronary artery disease\n* Eisenmenger syndrome\n* Complication of brain dysfunction due to circulatory failure\n* Malignant neoplasm\n* Complication of severe neurologic disorder\n* Severe pulmonary embolism or pulmonary hypertension\n* Severe renal failure\n* Multiple organ failure\n* Active infection (including endocarditis)\n* Sepsis\n* Active hemorrhagic disease (e.g. gastrointestinal bleeding, injury)\n* Known history of hypersensitivity to anti-infective drugs\n* Inability to complete the protocol treatment and baseline to follow-up examinations","0 Years","6 Years",{"count":265,"type":20},40,[267],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle",[270,144],"Hypoplastic Left Heart Syndrome",[272,273,274,149],"cardiac stem\u002Fprogenitor cells","autologous cell therapy","functional single ventricle","2025-09-24",{"date":277,"type":31},"2025-09-30",{"date":279,"type":4},"2016-06",{"date":281,"type":20},"2028-12",{"name":283,"class":284},"Metcela Inc.","INDUSTRY",4,{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":15,"minAge":292,"maxAge":293,"enrollmentInfo":294,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":295,"conditions":296,"keywords":298,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":39},"100598601","transcatheter-fontan-stenting-impact-on-hepatic-stiffness-and-exercise-capacity-100598601","NCT07073612","Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity","Inclusion Criteria:\n\n* Functionally single-ventricle Fontan-palliated patients undergoing clinically indicated cardiac catheterization\n* Anticipated Fontan stent placement for extracardiac Fontan conduit stenosis at the discretion of the primary operator\n* Weight ≥ 50 kg\n* 12-21 years of age\n\nExclusion Criteria:\n\n* Interrupted IVC\n* Greater than mild atrioventricular valve regurgitation on most recent echocardiogram or MRI (RF \\> 20%).\n* Greater than mild systemic ventricular dysfunction on most recent echo or MRI (EF \\\u003C 40%).\n* Non-sinus rhythm\n* Pacemaker\n* Inability to perform exercise test due to developmental or physical disability","12 Years","21 Years",{"count":51,"type":20},"The goal of this observational study is to assess the clinical impact following Fontan stent placement for extracardiac Fontan conduit (EFC) stenosis in patients with single-ventricle Fontan-palliated patients ages 12-21 years old.\n\nThe main question it aims to:\n\n-Assess changes in exercise capacity by cardiopulmonary exercise testing and liver stiffness assessed by shear wave elastography before and after EFC stenting.\n\nParticipants will undergo two cardiopulmonary exercise tests and three shear wave elastography scans.",[26,297],"Stenosis",[299,300,26],"Stent","fontan","2025-07-10",{"date":303,"type":31},"2025-07-18",{"date":305,"type":20},"2025-08-01",{"date":307,"type":20},"2027-12-01",{"name":309,"class":38},"Children's Hospital Los Angeles",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":21,"phases":320,"briefSummary":321,"conditions":322,"keywords":333,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":342,"locationsCount":39},"100398402","phase-2-two-year-study-of-the-safety-and-efficacy-of-the-second-generation-tissue-engineered-vascular-grafts-100398402","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.",{"count":319,"type":20},24,[185],"A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.",[323,324,325,326,327,328,26,329,330,331,332],"HLH - Hypoplastic Left Heart Syndrome","DORV","DILV - Double Inlet Left Ventricle","Mitral Atresia","Tricuspid Atresia","Unbalanced AV Canal","Heart Defects, Congenital","Cardiovascular Abnormalities","Cardiovascular Diseases","Heart Diseases",[88,334,335],"TEVG","Tissue Engineered Vascular Graft","2025-06-24",{"date":338,"type":31},"2025-06-27",{"date":340,"type":31},"2020-07-15",{"date":252,"type":20},{"name":343,"class":38},"Nationwide Children's Hospital",{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":15,"minAge":351,"maxAge":111,"enrollmentInfo":352,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":39},"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",{"count":19,"type":20},"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.",[355,26,356,357,358,359,360,327,361,362,363],"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":366,"type":31},"2025-06-17",{"date":368,"type":31},"2019-10-11",{"date":370,"type":20},"2025-12-01",{"name":372,"class":38},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":15,"minAge":110,"maxAge":380,"enrollmentInfo":381,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":383,"conditions":384,"keywords":390,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":39},"100575109","an-integrated-prenatal-and-postnatal-treatment-model-for-the-treatment-of-newborns-with-critical-congenital-heart-disease-100575109","NCT06768008","An Integrated Prenatal and Postnatal Treatment Model for the Treatment of Newborns With Critical Congenital Heart Disease","Clinical Study of an Integrated Prenatal and Postnatal Treatment Model to Improve the Treatment Effect of Newborns With Critical Congenital Heart Disease","Inclusion Criteria:\n\n1. Full-term infants (gestational age 37-40 weeks): age less than 28 days;\n2. Preterm infants (gestational age greater than 32 weeks but less than 37 weeks): corrected gestational age as neonatal period, age less than 28 days;\n3. Birth weight \\> 1.5 kg;\n4. Fetal diagnosis of congenital heart diseases by ultrasound at 22-26 weeks of gestation, suitable for biventricular repair.\n\nExclusion Criteria:\n\n1. Only suitable for palliative surgery or single ventricle repair;\n2. Associated genetic\u002Fchromosomal abnormalities;\n3. Associated with other severe systemic diseases.","28 Days",{"count":382,"type":20},10000,"The purpose of this two-way cohort study was to explore whether an integrated prenatal and postnatal treatment model for neonates with critical congenital heart disease (CCHD) could be effective in avoiding preoperative morbidities, creating an ideal timing for surgery, thereby reducing postoperative in-hospital mortality, and improving surgical prognosis compared with the traditional model of care. In addition, in neonates with CCHD associated with the right cardiac system, the investigators aim to further investigate whether early postnatal cardiac surgery has the potential advantage of obtaining a time window for myocardial regeneration and thus improving myocardial remodeling. The aim of this study is to improve the diagnostic and therapeutic capacity of critical congenital heart disease and to promote the integrated prenatal-postnatal treatment model for clinical use. This will ultimately improve the quality of healthcare services for patients with cardiovascular diseases and lay the foundation for exploring guidelines for the treatment of cardiovascular diseases suitable for China's national conditions.\n\nThe project will be jointly implemented by Beijing Anzhen Hospital , Capital Pediatric Research Institute, and 307 PLA General Hospital. Starting from January 1, 2022, the hospitals will continue to collect hospitalized cases of newborns with CCHD. The integrated prenatal and postnatal model is defined as a definitive diagnosis of CCHD in the fetal period (22-26 weeks), documentation of intrauterine transfer in our obstetrics department, subsequent initiation of an intrapartum or postpartum surgical plan after multidisciplinary consultation, and transfer to the pediatric heart center at the first hour of life, where the child is treated with either postpartum immediate or elective surgery, depending on patient status. For neonates who meet the indications for emergency surgery, surgery is performed immediately after birth. For neonates with non-emergency surgical indications, surgery is performed after birth adjustment to optimal status. The traditional model was defined as postpartum transfer via an outside hospital with routine interventions. The investigators then evaluate surgical prognosis and myocardial regenerative capacity to compare the effects of the two treatment models. This project will validate the advantages of an integrated prenatal and postnatal model over traditional models through real-world research and will improve prognosis in neonates with CCHD.",[86,356,385,361,386,142,387,144,145,360,388,389],"Aortic Stenosis","Pulmonary Stenosis","Truncus Arteriosus","Hypoplastic Left Heart Syndrome (HLHS)","Total Anomalous Pulmonary Venous Connection",[149,391,392,393,394],"Integrated prenatal and postnatal model","neonate","surgery","Myocardium regeneration","2025-01-05",{"date":397,"type":31},"2025-01-10",{"date":399,"type":31},"2022-01-01",{"date":401,"type":20},"2030-12-31",{"name":403,"class":38},"Beijing Anzhen Hospital",{"id":405,"slug":406,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":17,"enrollmentInfo":411,"targetDuration":4,"studyType":21,"phases":412,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":39},"100557473","association-of-near-infrared-spectroscopy-with-interstage-outcomes-100557473","NCT06538571","Association of Near Infrared Spectroscopy With Interstage Outcomes","Association of Renal Near Infrared Spectroscopy in Outpatients With Parallel Circulation During the Interstage Period and Interstage Morbidity","Inclusion Criteria:\n\n* Infants under 6 months of age\n* Infants with single ventricle heart disease and parallel circulation\n* Infants who are awaiting the Glenn operation\n* Infants who are outpatient\n\nExclusion Criteria:\n\n* Infants over 6 months of age\n* Inpatients\n* Infants with history of skin injury from the near infrared spectroscopy sensor inpatient\n* Infants with ongoing hyperbilirubinemia",{"count":51,"type":20},[23],"The purpose of this study is to assess the utility of renal near infrared spectroscopy in the outpatient setting during the interstage period. The primary aim will be to determine the correlation between oxygen extraction ratio ((arterial pulse oximetry - renal near infrared spectroscopy value)\u002Farterial pulse oximetry value) with need for inpatient admission or intervention. Secondary aims will be to determine the correlation of the oxygen extraction ratio with weight gain, neurodevelopment, unexpected admissions, systemic ventricular strain by echocardiography, and Glenn hospitalization admission characteristics.",[26],"2024-08-05",{"date":417,"type":31},"2024-08-07",{"date":419,"type":31},"2024-07-01",{"date":421,"type":20},"2026-07-01",{"name":423,"class":38},"Advocate Hospital System"]