[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypoplastic-left-heart-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypoplastic-left-heart-syndrome":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,81,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100570778","prenatal-maternal-mental-health-and-neurodevelopment-in-congenital-heart-disease-100570778",false,"NCT06711666","Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease","Prenatal Maternal Mental Health and Neurodevelopment in Children With an Antenatal Diagnosis of Congenital Heart Disease: The Neuro-Moms CHD Study","Neuro-Moms","Inclusion Criteria for the mother of a child diagnosed with CHD:\n\n1. Age at least 18 years old\n2. Expecting women\n3. Having received a diagnosis of foetal critical cyanotic CHD (i.e., CHD physiology that can compromise blood oxygenation after birth). This type of CHDs corresponds to the highest level of neurological risk as reported by the American Heart Association guidelines(1).\n4. Pregnancy of at least 28 weeks of gestation (third trimester) and up to the 38 weeks of gestation at the time of enrolment and prenatal visit for the study.\n5. Medical maternal and paediatric cardiology follow-up in one of the investigating hospitals (Montpellier, Necker Children's Hospital in Paris and Bordeaux).\n6. A delay of a minimum of 4 weeks between the initial diagnosis of foetal congenital heart disease.\n7. Social security affiliation in France.\n\nInclusion criteria for the father or co-parent:\n\n1. Co-parent of an expecting woman participating in the study\n2. Age at least 18 years old\n3. Social security affiliation in France.\n\nInclusion criteria for the child diagnosed with congenital heart disease:\n\n1. Child with a prenatal diagnosis of isolated complex congenital heart disease, born to a mother already participating in the study\n2. Written consent from both parents\n3. Social security affiliation in France.\n\nNon-inclusion Criteria for mothers:\n\n1. Patient refusal to participate\n2. Participants (i.e., expecting women) who express a wish for medical termination of pregnancy\n3. Diagnosis of a complex CHD associated with another foetal comorbidity with a clinically recognized impact on neurodevelopment (e.g., genetic syndromes such as trisomies, poly-malformation syndromes).\n4. Participants who are not able to understand the instructions and\u002For complete the self-reports\n5. Expecting women who currently have a major psychiatric condition (e.g., untreated major depression, severe anxiety disorders, psychotic disorders) with or without treatment, at the time of the cardiology consultation or at the time of the first psychological evaluation. Patients who will be excluded due to these conditions will be referred for perinatal psychiatric consultation.\n6. Persons under legal or judicial guardianship.\n\nNon-inclusion Criteria for fathers or co-parents:\n\n1. Patient refusal to participate\n2. Participants with a severe psychiatric disorder (severe depression, psychotic disorders) with or without treatment\n3. Persons under legal or judicial guardianship.\n\nExclusion Criteria for the mother of a child diagnosed with CHD:\n\n1\\. The child has not undergone surgery within 60 days of birth.\n\nExclusion Criteria for children with CHD:\n\n1\\. Genetic anomalies, brain malformations that may render difficult the neurodevelopmental assessment.","ALL","50 Years",{"count":20,"type":21},174,"ESTIMATED","OBSERVATIONAL","Congenital heart disease (CHD) is the leading cause of congenital malformations, representing 1% of live births. Progress in surgical care have led to the dramatic increase in the population of children and adults living with heart disease. As survival is no longer a concern, long-term outcomes have become the major public health issue. Prenatal diagnosis of CHD requiring open-heart surgery can be a traumatic event for expecting mothers and fathers. In the general population, maternal mental health distress is associated with fetal disturbances in the hypothalamic-adrenal-pituitary system axis, restricted intrauterine growth and adverse outcomes in the offspring. It is unknown whether prenatal maternal psychological distress have an impact on neurodevelopmental outcomes in CHD. Our national study seeks to (1) characterize the impact of prenatal maternal psychological distress on neurodevelopmental outcomes at age 1 for children with CHD who undergo neonatal open-heart surgery; (2) investigate the sociodemographic and medical determinants associated with prenatal maternal mental health of women carrying a foetus diagnosed with complex CHD; (3) explore the mediating role of prenatal risk factors (i.e., sociodemographic, medical and maternal coping mechanisms) in the association of prenatal maternal mental health (i.e., distress, anxiety and depression) and neurodevelopment in children with CHD; and (4) explore the impact of paternal or the co-parent's mental health impact on neurodevelopmental outcomes at age 1 in children with CHD. This study is a non-interventional, prospective, and longitudinal study of prenatal maternal mental health and subsequent child's neurodevelopmental and behavioural outcomes. It includes a follow-up period from the 3rd trimester of pregnancy until the child's first year of life. It will include children with a prenatally diagnosed heart defect requiring open-heart surgery within the first weeks of life. Understanding and preventing the neurodevelopmental sequelae of heart disease diagnosed in-utero is a public health priority.",[25,26,27,28],"Congenital Heart Disease","Cyanotic Congenital Heart Disease","d-Transposition of the Great Arteries","Hypoplastic Left Heart Syndrome",[30,31,32,33,34],"psychological stress","Maternal prenatal mental health","Neurodevelopment","Cyanotic congenital heart disease","Prenatal diagnosis","RECRUITING","2026-05-11",{"date":38,"type":39},"2026-05-12","ACTUAL",{"date":41,"type":39},"2025-06-27",{"date":43,"type":21},"2028-01",{"name":45,"class":46},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",5,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":5},"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":59,"type":21},40,"INTERVENTIONAL",[62],"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",[28,65],"Single Ventricle",[67,68,69,70],"cardiac stem\u002Fprogenitor cells","autologous cell therapy","functional single ventricle","congenital heart disease","2025-09-24",{"date":73,"type":39},"2025-09-30",{"date":75,"type":4},"2016-06",{"date":77,"type":21},"2028-12",{"name":79,"class":80},"Metcela Inc.","INDUSTRY",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":93,"studyType":22,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":108},"100468929","effect-of-fetal-aortic-valvuloplasty-on-outcomes-100468929","NCT05386173","Effect of Fetal Aortic Valvuloplasty on Outcomes","Effect of Fetal Aortic Valvuloplasty on Outcomes. A Prospective Observational Cohort Study With a Comparison Cohort","FASSprosp","Inclusion Criteria:\n\nA. All of the following echocardiographic criteria need to be satisfied between 23+0 and 31+6 weeks (z-scores according to Schneider et al):\n\n1. Aortic valve stenosis with antegrade flow through the valve\n2. Predominantly left-to-right shunt at the atrial level\n3. Predominantly retrograde flow in the aortic arch between the first two brachiocephalic vessels\n4. Qualitatively depressed left ventricular function\n5. Left ventricular end-diastolic diameter Z-score \\> ±0\n6. Left ventricular inlet length in diastole :\n\n   1. Gestational age ≤ 24+6: Z-score \\> ±0\n   2. Gestational age 25+0 to 27+6: Z-score \\> -0.75\n   3. Gestational age ≥ 28+0: Z-score \\> -1.50\n7. Mitral valve diameter in diastole Z-score \\> -2.0\n\nB. All of the following postnatal treatment options need to be available: 1. Surgical or catheter based aortic valvotomy 2. Ross-Konno surgery 3. Norwood or hybrid stage-one surgery\n\nExclusion Criteria:\n\n1. Any associated cardiac defect except persistent left superior vena cava and coarctation of the aorta\n2. Any significant (i.e. that might influence outcome) extracardiac anomaly and\u002For known chromosomal aberration. Also, if such a condition is present at inclusion but diagnosed only after birth the case will be retrospectively excluded.","23 Weeks","31 Weeks",{"count":92,"type":21},200,"3 Years","In one of the most severe congenital heart defects, hypoplastic left heart syndrome (HLHS), the left ventricle is underdeveloped and the prognosis is worse than in most other heart defects. The underdevelopment can occur gradually during fetal growth caused by a narrowing of the aortic valve. At some international centers, such fetuses are treated with a balloon dilation of the narrowed valve, but there is no scientifically sound evidence that this treatment is effective.\n\nThe aim of this study is: 1\u002F to evaluate whether balloon dilation during the fetal period of a narrowed aortic valve can reduce the risk of the left ventricle becoming underdeveloped and the baby being born with a so-called univentricular heart (HLHS); 2\u002F to investigate whether such treatment improves the prognosis for this group of children with a very complex and severe heart defect and 3\u002F to also describe side effects and risks in fetuses and mothers of the fetal procedure.",[25,96,97,28],"Aortic Valve Stenosis","Fetal Cardiac Disorder","2025-03-18",{"date":100,"type":39},"2025-03-21",{"date":102,"type":39},"2021-01-01",{"date":104,"type":21},"2029-12-31",{"name":106,"class":107},"Queen Silvia Children's Hospital, Gothenburg, Sweden","OTHER",13,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":60,"phases":118,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100551560","phase-1-study-of-intramyocardial-injection-of-ventrix-bio-extracellular-matrix-ventrigel-to-assess-the-safety-and-feasibility-in-pediatric-patients-with-hypoplastic-left-heart-syndrome-hlhs-100551560","NCT06461676","Study of Intramyocardial Injection of Ventrix Bio Extracellular Matrix (VentriGel) to Assess the Safety and Feasibility in Pediatric Patients with Hypoplastic Left Heart Syndrome (HLHS)","Inclusion Criteria:\n\n* Subjects with Hypoplastic Left Heart Syndrome (HLHS) requiring Stage II Glenn operation under one year of age\n\nExclusion Criteria:\n\n* Subjects undergoing the Stage II Glenn operations who do not have HLHS\n* Subjects requiring mechanical circulatory support within 5 days pre pre-surgical intervention\n* Parent or guardian unwilling or unable to comply with necessary follow-up(s)\n* Immunosuppressive diseases or subjects who require treatment with interventions that cause immunosuppression\n* A history of tumor or malignancy\n* Coagulation disorders\n* Chromosomal abnormalities that limit expected survival to \\\u003C 1 year\n* Abnormal lab values that may increase the risk of the study procedure (WBC \\>20,000 cells\u002Ful or \\\u003C 1,000 cells\u002Ful; platelet count \\\u003C 50,000 cells\u002Ful; Hgb \\\u003C 8.0 gm\u002Fdl; LFTs \\> 2x reference lab upper limit of normal) at the time of screening\n* Subjects with conduction abnormalities, including atrioventricular block and bundle branch blocks\n* Ventricular arrhythmias due to antiarrhythmic pharmacological therapy","1 Year",{"count":117,"type":21},12,[119],"PHASE1","The goal of this Phase I Open-Label study is to demonstrate the safety and feasibility of VentriGel injection in children with Hypoplastic Left Heart Syndrome (HLHS).\n\nThe main questions it aims to answer are:\n\n* Whether VentriGel is safe in treating patients with HLHS\n* Whether there are any preliminary improvements in measures of cardiac function following Ventrigel injection",[28],[123,124],"Stage II Glenn operation","HLHS","NOT_YET_RECRUITING","2025-03-06",{"date":128,"type":39},"2025-03-10",{"date":130,"type":21},"2025-08",{"date":132,"type":21},"2028-09",{"name":134,"class":107},"Emory University",1]