[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"congenital-heart-defects\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:congenital-heart-defects":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,63,99,125,154,185],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":20,"conditions":21,"keywords":24,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100242268","molecular-genetics-of-heterotaxy-and-related-congenital-heart-defects-100242268",false,"NCT02432079","Molecular Genetics of Heterotaxy and Related Congenital Heart Defects","Inclusion Criteria:\n\n* Subjects with heterotaxy and related congenital heart defects\n* Family members of subjects with heterotaxy and related congenital heart defects\n\nExclusion Criteria:\n\n* Subjects without heterotaxy and related congenital heart defects\n* Family members of subjects without heterotaxy and related congenital heart defects","ALL",{"count":17,"type":18},2000,"ESTIMATED","OBSERVATIONAL","The goal of this study is to obtain specimens and data from individuals and their families with heterotaxy and related congenital heart defects in order to clarify the molecular genetics of this disorder. The knowledge gained from the analysis of this information will provide the basis for future genetic counseling as well as contribute to knowledge about the biology of normal and abnormal development of left-right anatomic asymmetry.",[22,23],"Heterotaxy Syndrome","Congenital Heart Defects",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49],"Abnormalities, Multiple","Asplenia","Bilary Atresia","Birth Defect","Cardiovascular Abnormalities","Cardiovascular Diseases","Congenital Abnormalities","Congenital Heart Disease","Dextrocardia Syndrome","Disturbed Internal Organ Positioning","Genetics","Genetic Testing","Heart Defects, Congenital","Heart Diseases","Heterotaxy syndrome","Intestinal malrotation","Laterality","Left Atrial Isomerism","Pediatrics","Polysplenia","Right Atrial Isomerism","Splenic Diseases","Cilia","Situs inversus","Dextrocardia","RECRUITING","2026-06-17",{"date":53,"type":54},"2026-06-22","ACTUAL",{"date":56,"type":4},"2009-07",{"date":58,"type":18},"2030-12",{"name":60,"class":61},"Indiana University","OTHER",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100594470","impact-of-thymectomy-on-immunity-in-infants-after-cardiac-surgery-100594470","NCT07019857","Impact of Thymectomy on Immunity in Infants After Cardiac Surgery","Impact of Thymectomy on Immune Response in Infants 12 Months After Cardiac Surgery: a Single-centre Prospective Study","THYMIC","Inclusion Criteria:\n\n* \\- Children aged between 0 and 6 months;\n* Born at a gestational age \\> 37 weeks' gestation;\n* With an indication for cardiac surgery under CEC at Nantes University Hospital;\n* Cardiopediatric follow-up planned at Nantes University Hospital;\n* Written agreement signed by legal guardians to participate in the study.\n\nFor the control groups:\n\n* Control group A (cardiac surgery without thymectomy):\n\n  * Children aged between 0 and 6 months of age;\n  * Born at a gestational age \\> 37 SA;\n  * Indicated for thoracotomy cardiac surgery at Nantes University Hospital;\n  * Cardiopediatric follow-up planned at Nantes University Hospital;\n  * Written agreement signed by legal guardians to participate in the study.\n* Control group B (non-cardiac surgery)\n\n  * Children aged between 0 and 6 months;\n  * Born at a gestational age \\> 37 SA;\n  * Indicated for non-cardiac surgery (ENT or visceral surgery at Nantes University Hospital);\n  * Planned follow-up surgery at Nantes University Hospital;\n  * Written agreement signed by legal guardians to participate in the study.\n\nExclusion Criteria :\n\n* Gestational age \\\u003C 37 SA;\n* With a history of cardiac surgery under ECG;\n* And\u002For with heart disease requiring further surgery within 12 months of the 1st surgery (e.g. pulmonary cerclage, systemic pulmonary anastomosis).\n* And\u002For a history of partial or complete thymectomy;\n* Receiving long-term immunosuppressive treatment;\n* Post-operative follow-up planned in a hospital other than Nantes University Hospital, or moving house planned during the follow-up period;\n* parental refusal.\n\nExclusion Criteria:\n\n* \\- Gestational age \\\u003C 37 SA;\n* With a history of cardiac surgery under ECG;\n* And\u002For with heart disease requiring further surgery within 12 months of the 1st surgery (e.g. pulmonary cerclage, systemic pulmonary anastomosis).\n* And\u002For a history of partial or complete thymectomy;\n* Receiving long-term immunosuppressive treatment;\n* Post-operative follow-up planned in a hospital other than Nantes University Hospital, or moving house planned during the follow-up period;\n* parental refusal.","6 Months",{"count":73,"type":18},70,"INTERVENTIONAL",[76],"NA","Heart surgery in infants typically involves complete removal of the thymus gland to improve access to the heart. However, the thymus plays a key role in developing the immune system in early childhood, especially in the production and maturation of T lymphocytes, which help the body defend itself against infections.\n\nThe THYMIC study tests the hypothesis that partial removal of the thymus (partial thymectomy) during heart surgery may better preserve the child's immune function compared to total removal (complete thymectomy). The goal is to determine whether this conservative surgical approach could reduce the risk of immune system impairment and infections in the months following surgery.\n\nThis is a prospective, interventional, single-center study conducted at CHU de Nantes, involving 3 groups of infants:\n\n* One group undergoing heart surgery with complete thymectomy;\n* One group undergoing heart surgery with partial thymectomy;\n* One control group undergoing heart or non-heart surgery without thymus removal. All infants enrolled will have two blood tests: one taken during their surgery and one taken one year later. These blood tests will quantify immune cells (T, B, NK cells), levels of antibodies, and vaccine responses. Parents will also be asked to fill out a questionnaire to record any infections their child experiences during the year after surgery.\n\nBy comparing the immune responses and infection rates among the groups, the researchers hope to better understand the long-term effects of thymectomy in infants. The results could support future recommendations to preserve part of the thymus when possible during heart surgery.\n\nParticipation in the study does not change the medical or surgical care of the child. The decision to perform a partial or complete thymectomy is made by the surgeon based on the child's anatomy. The additional blood samples are small in volume and follow current safety regulations.",[23,79,80],"Thymectomy","Immunological Deficiency Syndrome",[79,82,83,84,85,86,87,88],"Cardiac Surgery","Infant","Immunity","Lymphocytes","TRECs","Vaccination","Infection","2026-04-13",{"date":91,"type":54},"2026-04-16",{"date":93,"type":54},"2025-07-25",{"date":95,"type":18},"2027-12-01",{"name":97,"class":61},"Nantes University Hospital",2,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":15,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":74,"phases":111,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"100550094","characterization-and-support-for-neurodevelopmental-disorders-associated-with-congenital-heart-defects-100550094","NCT06442592","Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects","CATAMARAN - Pediatrics : Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects","CATAMARAN Ped","Inclusion Criteria:\n\n* Child (aged 3 to 11) with critical MCC operated on for heart surgery during the first three months of life\n* Parents and child affiliated with or benefiting from a social security or similar scheme\n* Parents' and child's good understanding of the French language\n* Free, informed and written consent of both parents for themselves and for the child\n* Free, informed and written consent of the child aged 6 and over\n* Biological parents\n\nExclusion Criteria:\n\n* Genetic anomaly or malformative syndrome associated with neurodevelopmental abnormalities, identified prior to inclusion\n* Neurodevelopmental assessment not practicable","3 Years","11 Years",{"count":110,"type":18},1206,[76],"The leading cause of birth defects, Congenital Heart Defects (CHD) affect 12 million people worldwide and 41,000 newborns\u002Fyear in Europe. It's a major cause of life-long morbidity and mortality, and a crucial public health issue. More than 50% of childs born with critical CHD will develop Neurodevelopmental Disorders (NDs), requiring specific care and impairing quality of life. NDs corresponds to early and lasting disturbances in cognitive, affective and behavioral development, linked to abnormalities in brain development. They are heterogeneous, affecting language, learning, motor skills, intellectual efficiency, social cognition, attention, memory and executive functions, and are associated with psychosocial difficulties (adaptive behavior, social interactions). This hidden handicap is the main long-term sequels of CHD, even before cardiovascular sequels, in individuals who often underwent multiple heart operations in early childhood. NDs concern not only complex CHD, but also simple CHD repaired in childhood and considered cured.\n\nThe origin of TND associated with CHD is largely unknown. To date, few genetic or environmental causes have been clearly identified, but recent work has suggested that a common origin may link cardiac malformation and neurodevelopmental abnormality.\n\nThe CATAMARAN - Pediatrics project is designed to detect potential neurodevelopmental delays associated with CHD as early as age 3, and to identify individual susceptibility factors involved in the occurrence of NDs in CHD children.",[23,114],"Neurodevelopmental Disorder",[23,114,35],"2026-03-30",{"date":118,"type":54},"2026-04-03",{"date":120,"type":54},"2024-07-08",{"date":122,"type":18},"2027-08-08",{"name":97,"class":61},5,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":15,"minAge":133,"maxAge":4,"enrollmentInfo":134,"targetDuration":136,"studyType":19,"phases":4,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":62},"100596063","bioabsorbable-occluder-for-outlet-vsd-safety-and-aortic-valve-effects-100596063","NCT07040579","Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects","Transcatheter Bioabsorbable Occluder Closure for Outlet Ventricular Septal Defect: Safety, Effectiveness and Impact on Aortic Valve Function","ABSORB-VSD","Inclusion Criteria:\n\n* Age ≥1 year and weight ≥10 kg\n* Outlet VSD without ventricular malalignment\n* Maximal defect diameter ≤12mm with subaortic rim ≤1mm and no ≥mild aortic regurgitation by by transthoracic or transesophageal echocardiography\n* Written informed consent\n\nExclusion Criteria:\n\n* Outlet VSD with a fibrous postero-inferior rim\n* Concurrent cardiac conditions requiring surgical correction\n* Severe pulmonary hypertension (PVR \\> 5 WU, assessed by right heart catheterization )\n* Intracardiac thrombus\n* Pregnancy\n* Active systemic infection within 1 month","1 Year",{"count":135,"type":18},50,"5 Years","This study aims to evaluate the efficacy and safety of transcatheter bioabsorbable occluder closure in patients with outlet-type ventricular septal defect (outlet VSD), with a focus on assessing its impact on aortic valve function.",[23,139],"VSD",[141,142,143],"transcatheter","bioabsorbable occluder","outlet VSD","NOT_YET_RECRUITING","2025-06-18",{"date":147,"type":54},"2025-06-27",{"date":149,"type":18},"2025-06-30",{"date":151,"type":18},"2032-12-31",{"name":153,"class":61},"First Affiliated Hospital of Guangxi Medical University",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":15,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":74,"phases":165,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":62},"100536671","early-phase-1-development-of-methods-for-effective-treatment-and-improvement-of-common-somatic-diseases-in-children-100536671","NCT06267859","Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children","Based on Medical Statistical Analysis and Screening (Dispensary) Examination, Identification of the Most Common Somatic and Congenital Diseases in Children, With the Further Development of More Effective Methods of Treatment and Recovery","Inclusion Criteria:\n\n* children from birth to 15 years;\n* children permanently residing in the territory where the clinical examination is carried out;\n* children included in the group of \"frequently ill children\";\n* patients without severe chronic diseases.\n\nExclusion Criteria:\n\n* Teenagers over 15 years old;\n* Patients with severe neurological and mental diseases;\n* Patients with endocrinological diseases;\n* Patients with long-term chronic somatic diseases;\n* Children without genetic pathologies.","3 Days","15 Years",{"count":164,"type":18},110,[166],"EARLY_PHASE1","The goal of the clinical study is to clarify the course of common congenital, infectious, and non-infectious diseases in children living in Uzbekistan, and to develop methods for their treatment and rehabilitation.\n\nThe main questions it aims to answer:\n\n* Analysis of common congenital diseases among children;\n* Analysis of commonly diagnosed bronchopulmonary and cardiovascular diseases among children;\n* Based on the results of the primary research, common diseases among children will be identified;\n* Analysis of existing treatment methods and their effectiveness;\n* Development of modern methods of treatment and rehabilitation of children.",[169,23],"Respiratory Diseases",[171,172,173,174,175],"children","adolescents","heart diseases","lung diseases","congenital malformations","2025-05-16",{"date":178,"type":54},"2025-05-21",{"date":180,"type":54},"2023-11-08",{"date":182,"type":18},"2034-01-30",{"name":184,"class":61},"Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":192,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":74,"phases":195,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":62},"100279904","creation-of-a-french-south-eastern-database-and-dna-bank-of-congenital-heart-disease-to-explore-the-genetic-pathways-100279904","NCT02923440","Creation of a French South-Eastern Database and DNA-bank of Congenital Heart Disease to Explore the Genetic Pathways","SEA-HD","Inclusion Criteria:\n\n* Echocardiographic diagnosis of congenital heart defect falling within the classification Houyel and Bonnet\n* Necessity of making a blood test regardless of study\n* Medical care in the AP-HM Timone Hospital children, medical-surgical unit of pediatric and congenital cardiology, Marseille - These Parent Child\n\nExclusion Criteria:\n\n* Pregnant women\n* Patients or parent \u002F legal guardian (if minor) in physical or mental incapacity to understand or sign the consent\n* People in Emergencies\n* Persons deprived of freedom\n* Persons not beneficiaries of a social security scheme\n* Persons in health or social institution",true,{"count":194,"type":18},300,[76],"Congenital heart defects are seen in 0,8% of life births. In France this means more than 5000 newborns per year. The south-east region of France is particularly affected as a result of a higher birth rate and consanguinity, when compared to other regions. The majority of congenital heart diseases remain unexplained. Genetic causes are indisputable but remain poorly understood. Genetic research needs the availability of a large-scale DNA collection, guided by a robust phenotypic classification. Such a DNA-bank has been created in Paris (CARREG DNA bank, created by the M3C reference centre for congenital heart diseases). Such a bank is currently unavailable in south-east France. To transport biological specimens from Marseille to Paris would be very expensive. In addition, the whole infrastructure required for correct diagnosis and classification of the congenital heart diseases, for sampling, for storage of the samples and genetic analysis, does exist in our AP-HM hospital and in our AMU research unit. For those reasons it is highly preferable to elaborate such a database and DNA-bank locally. The acronym SEA-HD (South-EAst-Heart-Diseases) would be used to name this DNA-bank",[23],"2023-03-09",{"date":200,"type":54},"2023-03-13",{"date":202,"type":54},"2017-01-17",{"date":204,"type":18},"2028-03",{"name":206,"class":61},"Assistance Publique Hopitaux De Marseille"]