[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-defects-congenital\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-defects-congenital":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,48,72,93,123,156,198,221,251,286,309,341],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100516323","congenital-heart-disease-physical-activity-lifestyle-study-v2-100516323",false,"NCT06003023","Congenital Heart Disease Physical Activity Lifestyle Study V.2","Establishing Efficacy for the Congenital Heart Disease Physical Activity Lifestyle Intervention","CHD-PALS V2","Inclusion Criteria:\n\n* Between the ages of 15-25 years\n* Diagnosed with moderate or complex structural CHD\n* Actively receiving care from a cardiologist at Nationwide Children's Hospital (NCH) or Ohio State University (OSU)\n\nExclusion Criteria:\n\n* Unable to speak and read proficiently in English\n* Have a diagnosis of a genetic syndrome that impacts multiple organ systems\n* Have cognitive impairments that would interfere with completing study measures\n* Have been engaged in a formal exercise program within the past 6 months,\n* Have participated in the intervention arm of the previous CHD-PAL Study\n* Have undergone open-heart surgery or had a valve replacement in the last 3 months\n* Are unable to complete an exercise stress test using a treadmill\n* Are pregnant\n* Are prohibited to engage in at least moderate levels of physical activity by their cardiologist\n* Engage in \\>30 minutes of moderate-to-vigorous physical activity per day, on average per accelerometer\n* Have contraindications for exercise based on an exercise stress test (e.g., exercise-induced arrhythmias or evidence of cardiac ischemia)","ALL","15 Years","25 Years",{"count":21,"type":22},144,"ESTIMATED","INTERVENTIONAL",[25],"NA","The Congenital Heart Disease Physical Activity Lifestyle Intervention Study (CHD-PALS) V.2 seeks to determine the efficacy of a lifestyle intervention program for adolescents and young adults (AYAs) with congenital heart disease (CHD). This trial was adapted from the original CHD-PAL trial to continue improving cardiovascular outcomes for transition-aged CHD survivors.",[28,29],"Heart Defects, Congenital","Cardiovascular Disease Other",[31,32,33,34],"congenital heart disease","physical activity","adolescents","young adults","RECRUITING","2026-05-28",{"date":38,"type":39},"2026-06-01","ACTUAL",{"date":41,"type":39},"2023-07-18",{"date":43,"type":22},"2027-07-30",{"name":45,"class":46},"Jamie Jackson","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":47},"100262136","genes-associated-with-development-of-pulmonary-arterial-hypertension-in-patients-with-congenital-shunt-lesions-100262136","NCT02691689","Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions","Prospective, Monocentric Pilot Study for the Identification of Known or Novel Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions","Inclusion Criteria:\n\n* Previous diagnosis of secundum atrial septal defect (ASD) or ventricular septal defect (VSD), with or without repair\n* Development of PAH, defined as mean PAP ≥ 25 mmHg by right heart catheterization, in combination with a pulmonary wedge pressure of ≤ 15 mmHg and a PVR (pulmonary vascular resistance) of \\> 3 Wood units\n* Preferably, families with congenital shunt lesions (at least three family members affected with ASD or VSD) will be considered for inclusion\n\nExclusion Criteria:\n\n* Other congenital heart disease\n* Mental retardation\n* Dysmorphic characteristics\n* Chronic lung disease or total lung capacity \\\u003C 80% of predicted value\n* History of pulmonary embolism","18 Years",{"count":57,"type":22},21,[25],"Pulmonary arterial hypertension (PAH) in patients with congenital heart disease (CHD) is associated with considerable morbidity and even mortality.\n\nNext to environmental risk factors, the investigators believe that there is an important role of genetic predisposition to develop PAH in CHD. There often is a discrepancy between the severity of PAH and the CHD, where it is useful to screen for PAH gene mutations. The investigators hypothesize that the genotype is partly responsible for the phenotypic variability in patients with congenital shunt lesions, where some develop PAH and others do not. If a genetic predisposition for PAH in CHD could be identified, then genetic screening could be a useful additional tool for early detection of patients at risk of pulmonary vascular disease and PAH development, with new opportunities for prevention or early treatment.",[28,61,62],"Pulmonary Arterial Hypertension","Genetic Testing","2026-04-27",{"date":65,"type":39},"2026-04-29",{"date":67,"type":39},"2015-11",{"date":69,"type":22},"2027-02",{"name":71,"class":46},"Universitaire Ziekenhuizen KU Leuven",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":78,"maxAge":55,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":89,"leadSponsor":91,"locationsCount":47},"100571366","long-term-effects-of-family-wish-program-for-adolescents-with-congenital-heart-disease-100571366","NCT06719323","Long-term Effects of Family WISH Program for Adolescents With Congenital Heart Disease","Inclusion Criteria:\n\n* being between 12 and 18 years old;\n* having received a diagnosis of CHD by a physician before age 2;\n* having received a diagnosis of CHD with New York Heart Association (NYHA) functional class I, II, or III;\n* having parents or guardians who were able to communicate in Mandarin, and being able to communicate in Mandarin themselves;\n* not having cognitive impairments, and;\n* voluntarily signing informed consent forms.\n\nExclusion Criteria:\n\n* undergoing heart transplant surgery within the past year;\n* receiving cardiac catheterization intervention or open-heart surgery within the past 6 months;\n* having CHD with NYHA functional class IV; and\n* having other congenital diseases","12 Years",{"count":80,"type":22},104,[25],"The goal of this clinical trial is to learn the long-term effects of \"Family Walking Instruction with Support by Heart\" (Family WISH) on frailty state, quality of life and family functioning among adolescents with congenital heart disease (CHD).\n\nResearchers will compare the 12-week Family WISH program, based on self-efficacy theory, to a comparison group receiving a family walking health education sheet to evaluate the long-term effectiveness of the Family WISH program.\n\nParticipants will:\n\n* Walk with family members for 20-30 minutes daily, at least 5 times per week, totaling 150 minutes per week.\n* Keep a diary to record the frequency of their walks and any symptoms experienced.\n* Complete questionnaires at baseline, and at 6, 12, and 24 weeks.",[28],"NOT_YET_RECRUITING","2026-01-08",{"date":87,"type":39},"2026-01-12",{"date":38,"type":22},{"date":90,"type":22},"2027-07-31",{"name":92,"class":46},"Chi-Wen Chen",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":4},"100616034","study-on-the-safety-and-effectiveness-of-a-biodegradable-patent-foramen-ovale-occluder-system-100616034","NCT07300358","Study on the Safety and Effectiveness of a Biodegradable Patent Foramen Ovale Occluder System","BIOCLOSE-PFO Study：Evaluation of the Safety and Efficacy of a Biodegradable Patent Foramen Ovale Occluder System: A Prospective, Multicenter, Randomized Controlled, Non-Inferiority Clinical Study","BIOCLOSE-PFO","Inclusion Criteria:\n\n* Aged between 18 and 65 years.\n* Presence of a patent foramen ovale (PFO) confirmed by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE).\n* Presence of a moderate-to-large right-to-left shunt (RLS) at rest or during the Valsalva maneuver, as confirmed by agitated saline contrast echocardiography (also known as bubble study).\n* Clinically diagnosed with a PFO-associated ischemic stroke or transient ischemic attack (TIA).\n\nExclusion Criteria:\n\n* An alternative, clearly identified cause of ischemic stroke or TIA (other than PFO) is determined by the investigator.\n* Large territory cerebral infarction within 4 weeks prior to the planned procedure.\n* Atherosclerotic stenosis (\\>50%) of the carotid or vertebral arteries, as confirmed by CT angiography or vascular ultrasound per investigator assessment.\n* Presence of intracardiac thrombus or vegetation as confirmed by echocardiography.\n* Left ventricular ejection fraction (LVEF) \\\u003C 35%.\n* Atrial fibrillation or atrial flutter.\n* Left ventricular aneurysm or severe regional wall motion abnormality.\n* Significant valvular stenosis or regurgitation, or history of valvular replacement or repair surgery.\n* Pulmonary hypertension or a PFO constituting a special conduit (e.g., right-to-left shunt due to elevated right heart pressures).\n* Other confirmed causes of right-to-left shunt, such as atrial septal defect (ASD) or pulmonary arteriovenous fistula.\n* Complex PFO anatomy (e.g., multi-tunnel PFO) or PFO associated with an ASD requiring different closure strategy.\n* Thrombus, mass, or vegetation identified at the intended implant site or along the potential delivery pathway.\n* Acute myocardial infarction or unstable angina within 3 months prior to the procedure.\n* Previous implantation of an inferior vena cava filter, PFO closure device, or ASD closure device.\n* Any other condition deemed by the investigator to make the patient unsuitable for PFO device implantation.\n* Concomitant cardiac anomalies requiring surgical correction.\n* Uncontrolled systemic or local infection, or sepsis.\n* Active infection requiring concurrent antibiotic therapy (Patients with transient conditions may be enrolled after completing antibiotic therapy and a subsequent 14-day washout period).\n* Contraindication to antiplatelet or anticoagulant therapy (e.g., major bleeding within 3 months, known retinopathy, history of intracranial hemorrhage, or other significant intracranial pathology).\n* Known hypersensitivity or allergy to tantalum or nickel.\n* Pregnancy, lactation, or women of childbearing potential not using highly effective contraception.\n* Life expectancy less than 1 year due to malignancy or other comorbid disease.\n* Current participation in another investigational drug or device clinical study that has not yet completed its primary endpoint.","65 Years",{"count":103,"type":22},258,[25],"To evaluate the Safety and Efficacy of a Novel Biodegradable Occluder for Percutaneous Closure of Patent Foramen Ovale (PFO)",[107,108,28,109,110,111,112,113],"Cardiovascular Diseases","Cardiovascular Abnormality","Heart Septal Defects","Heart Septal Defects, Atrial","Foramen Ovale, Patent","Stroke, Ischemic","Stroke (CVA) or TIA","2025-12-09",{"date":116,"type":39},"2025-12-23",{"date":118,"type":22},"2025-12-30",{"date":120,"type":22},"2027-06-30",{"name":122,"class":46},"Shanghai Lingsi Medical Technology Co., Ltd.",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":131,"sex":17,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":136,"phases":4,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":47},"100493770","mind-the-heart---mental-health-in-children-and-adolescents-with-congenital-heart-defects-100493770","NCT05709470","Mind the Heart - Mental Health in Children and Adolescents With Congenital Heart Defects","Mind the Heart - Mental Health in Children and Adolescents With Congenital Heart Defects in Denmark","Mind the Heart","Inclusion Criteria:\n\n* Born with a Congenital Heart Defect\n* Age 5-17y\n* (Living in Denmark)\n\nExclusion Criteria:\n\n* Younger than 5years of age\n* Older than 17years of age\n* Lacking sufficient Danish language skills to answer the questionnaire",true,"5 Years","17 Years",{"count":135,"type":22},4800,"OBSERVATIONAL","The aim of the Mind the Heart study is to document the feasibility of an online parent\u002Fchild administered screening model for mental disorders (MDs) in Danish children and adolescents with congenital heart disease (CHD). As MDs in children and adolescents with chronic somatic health issues are frequently underdiagnosed and undertreated, we further aim to develop a website with evidence based information on mental health in children and adolescents with CHD in order to promote knowledge and awareness among families and health professionals across sectors.",[28,139],"Mental Health Issue",[28,141,142,143,144,145,146],"Mental Health","Child","Adolescent","Surveys","Questionnaires","Psychiatry","2025-09-22",{"date":149,"type":39},"2025-09-26",{"date":151,"type":39},"2023-03-17",{"date":153,"type":22},"2025-12-31",{"name":155,"class":46},"Rigshospitalet, Denmark",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":23,"phases":166,"briefSummary":167,"conditions":168,"keywords":173,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":197},"100529540","heartgps-a-study-exploring-the-effects-of-a-psychological-intervention-for-parents-and-their-babies-after-prenatal-cardiac-diagnosis-100529540","NCT06175104","HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis","HeartGPS: A Longitudinal Randomized Controlled Trial Examining the Effects of a Prenatally-Delivered Psychological Intervention for Parents and Their Babies With Single Ventricle Congenital Heart Disease","HeartGPS","Inclusion Criteria\n\n1. Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD).\n2. Single ventricle CHD diagnosis between 16 and 30 weeks gestation.\n3. Singleton pregnancy.\n4. Pregnant person is planning to continue with the pregnancy.\n5. Pregnant person is able to participate and complete study assessments in English.\n\nExclusion Criteria\n\n1. Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome).\n2. Fetal or maternal medical condition determined by treating physician to be contraindicative to study participation.\n3. Parent with an untreated major psychiatric condition, substance use disorder, or other circumstances that would interfere with study engagement or safe participation in the trial.\n4. Parent with a moderate to severe intellectual disability.\n5. Parent age \\\u003C18 years.\n6. Surrogate for pregnancy.\n\nPrenatal administration of oral or intravenous corticosteroids for fetal lung maturation will be recorded but are not a reason for exclusion.",{"count":165,"type":22},50,[25],"Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.",[28,169,170,171,172],"Anxiety in Pregnancy","Depression, Postpartum","Trauma, Psychological","Neurodevelopmental Disorders",[174,175,141,176,177,178,179,180,181,182,183,184,185,186,187],"Congenital Heart Disease","Prenatal","Neurodevelopment","Neurobehavior","Fetal Cardiology","Psychological Intervention","Mother-Infant Attachment","Mother-Infant Bonding","Medical Traumatic Stress","Neuroimaging","Brain Development","Fetal Neuroimaging","Perinatal Mental Health","Medical Psychology","2025-07-16",{"date":190,"type":39},"2025-07-20",{"date":192,"type":22},"2025-07-14",{"date":194,"type":22},"2027-12",{"name":196,"class":46},"Children's Hospital Medical Center, Cincinnati",4,{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":55,"enrollmentInfo":205,"targetDuration":4,"studyType":23,"phases":207,"briefSummary":202,"conditions":208,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":47},"100597530","high-flow-nasal-cannula-vs-niv-after-extubation-in-children-undergoing-heart-surgery-100597530","NCT07059689","High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery","High Flow Nasal Cannula vs. Non-Invasive Ventilation in Post-Extubation Pediatric Cardiac Surgery Patients: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients under 18 years of age.\n* Post-cardiac surgery patients in the CICU of Cipto Mangunkusumo National General Hospital\n* Patients at high risk of extubation failure (e.g., young age, open sternotomy, mechanical ventilation \\>48 hours).\n* Patients who pass the extubation readiness test and spontaneous breathing trial.\n\nExclusion Criteria:\n\n* Diaphragmatic paralysis.\n* Decreased consciousness.\n* Neuromuscular disease.\n* Pneumothorax without drainage.\n* Airway obstruction.\n* Patients with a tracheostomy.\n* Unplanned extubation.\n* Patient received PEEP (Positive End-Expiratory Pressure) \\>7 prior to extubation",{"count":206,"type":22},114,[25],[28,209,210,211],"Intensive Care Units, Pediatric","Respiration, Artificial","Extubation","2025-07-07",{"date":214,"type":39},"2025-07-11",{"date":216,"type":39},"2025-06-05",{"date":218,"type":22},"2025-12",{"name":220,"class":46},"Indonesia University",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":131,"sex":17,"minAge":227,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":136,"phases":4,"briefSummary":230,"conditions":231,"keywords":237,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":47},"100597195","development-and-improvement-of-home-rehabilitation-scheme-for-preschool-children-with-congenital-heart-disease-after-operation-100597195","NCT07055334","Development and Improvement of Home Rehabilitation Scheme for Preschool Children With Congenital Heart Disease After Operation","Children With Congenital Heart Disease After Surgery\n\nInclusion Criteria:\n\n* Age 3 to 7 years\n* Clinical diagnosis of congenital heart disease\n* Underwent a single open-heart surgical correction under direct vision at the study site\n* Ability to communicate in Chinese\n\nExclusion Criteria:\n\n* Postoperative arrhythmia\n* Comorbid neurological, respiratory, or other systemic diseases\n* Deemed unsuitable for exercise by a physician\n* Cardiac function classified as NYHA Class IV\n* Intellectual, language, or motor impairments resulting from perioperative complications or other causes\n\nCaregivers of Children With Congenital Heart Disease After Surgery\n\nInclusion Criteria:\n\n* Primary caregiver who voluntarily provides care\n* Caregiver who spends the most time with the child\n* Ability to communicate in Chinese\n\nExclusion Criteria:\n\n* Caregivers of children who voluntarily discontinued treatment before completion\n* Paid or professional caregivers\n* Diagnosed cognitive impairment or mental illness\n* Inability to communicate effectively through spoken language\n* Presence of serious conflict or instability in the caregiver-child relationship\n* Inability to independently operate or use smart electronic devices and the internet\n\nMedical Professionals Involved in Congenital Heart Disease Care\n\nInclusion Criteria:\n\n* Licensed healthcare professionals, including physicians, nurses, dietitians, physical therapists, or psychological counselors\n* At least 5 years of professional experience in congenital heart disease care, rehabilitation, or education\n\nExclusion Criteria:\n\n* Not currently engaged in frontline clinical work\n* Not engaged in clinical work within the past year due to leave, study, or reassignment","3 Years",{"count":229,"type":22},30,"This part of the study focuses on understanding the home rehabilitation situation for preschool children with congenital heart disease after operation. Qualitative research interviews with caregivers and medical staff (including doctors, nurses, rehabilitation therapists, nutritionists, and psychologists) are conducted to explore the benefits, obstacles, and professional guidance needs of home rehabilitation. The aim is to summarize the best evidence for home rehabilitation through evidence-based nursing and qualitative research, in order to develop a more comprehensive and suitable home rehabilitation scheme for these children.",[28,232,233,234,235,236],"Rehabilitation","Preschool Child","Qualitative Research","Caregivers","Medical Staff, Hospital",[31,238,239,240,241],"home-based cardiac rehabilitation","Primary caregiver","qualitative research","preschool child","2025-06-27",{"date":244,"type":39},"2025-07-08",{"date":246,"type":22},"2025-07-10",{"date":248,"type":22},"2026-12-31",{"name":250,"class":46},"Wei XIA, PhD",{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":261,"briefSummary":263,"conditions":264,"keywords":274,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":47},"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":260,"type":22},24,[262],"PHASE2","A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.",[265,266,267,268,269,270,271,28,272,107,273],"HLH - Hypoplastic Left Heart Syndrome","DORV","DILV - Double Inlet Left Ventricle","Mitral Atresia","Tricuspid Atresia","Unbalanced AV Canal","Single-ventricle","Cardiovascular Abnormalities","Heart Diseases",[275,276,277],"Fontan","TEVG","Tissue Engineered Vascular Graft","2025-06-24",{"date":242,"type":39},{"date":281,"type":39},"2020-07-15",{"date":283,"type":22},"2027-08",{"name":285,"class":46},"Nationwide Children's Hospital",{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":19,"enrollmentInfo":293,"targetDuration":4,"studyType":23,"phases":295,"briefSummary":296,"conditions":297,"keywords":298,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":307,"locationsCount":4},"100530312","effects-of-rehabilitation-programme-on-respiratory-function-in-patients-with-acquired-and-intervened-congenital-heart-disease-100530312","NCT06185140","Effects of Rehabilitation Programme on Respiratory Function in Patients with Acquired and Intervened Congenital Heart Disease.","Effects of Rehabilitation Programme on Respiratory Function in Patients with Acquired and Intervened Congenital Heart Disease: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Pediatric patients with a history of cardiac transplantation or acquired congenital heart disease who have undergone at least one interventional procedure or surgical intervention at least 6 months before the start of the program in a state of clinical stability, hemodynamic stability, and ECG stability. They should have residual hemodynamic defects of sufficient severity that potentially restrict participation, and their perception of fragility may be influenced by the social, family, school environment, or by the patient themselves.\n* Children aged 6-15 years at the start of the study.\n* Children with maximum predicted oxygen consumption (VO2 max) values \\\u003C80%, as measured in ergospirometry 6 months before the start of the intervention program.\n* Patients for whom consultation with a pediatric cardiology specialist and pediatric rehabilitation specialist has not revealed contraindications for exercise.\n* Children and their legal representatives should have provided informed consent and the ability to travel to the hospital center for in-person intervention.\n\nExclusion Criteria:\n\n* Patients with acute, inflammatory, or infectious health conditions that could pose a risk to them during the course of the program.\n* Patients who have undergone at least one interventional procedure or surgical intervention within a period of less than 6 months before the start of the study.",{"count":294,"type":22},26,[25],"Congenital heart defects (CHDs) are heart malformations that occur before birth, and they represent one of the leading causes of neonatal morbidity and mortality. they occur in approximately 1% of newborns and are associated with high morbidity and mortality rates. The etiology of these cardiac anomalies is mostly unknown. around 70-80% of cases are generated by the involvement of multiple affected genes combined with an environmental trigger that, when acting on a susceptible individual, promotes the expression of the damaged genome. maternal diseases during pregnancy or exposure to teratogenic substances are also implicated in the etiology.",[28],[299,300],"Exercise","Physiotherapy","2024-12-03",{"date":303,"type":39},"2024-12-06",{"date":305,"type":22},"2025-01-01",{"date":153,"type":22},{"name":308,"class":46},"University of Salamanca",{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":317,"targetDuration":132,"studyType":136,"phases":4,"briefSummary":319,"conditions":320,"keywords":327,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":340},"100522998","european-prospective-registry-on-anomalous-aortic-origin-of-the-coronary-arteries-100522998","NCT06089902","European Prospective Registry on Anomalous Aortic Origin of the Coronary Arteries","EUROAAOCA Registry","EUROAAOCA","Inclusion Criteria:\n\n* All patients with a diagnosis of AAOCA (either referred to surgery or to medical follow-up )\n\nExclusion Criteria:\n\n* isolated high-coronary take-off (≥ 5mm above sino-tubular junction), anomalous origin of a circumflex from the right coronary artery, anomalous course with a normal origin, and association to major congenital heart disease (i.e. Tetralogy of Fallot, transposition of the great arteries, anomalous origin of a coronary from the pulmonary artery).",{"count":318,"type":22},500,"Anomalous aortic origin of a coronary artery (AAOCA) is a group of rare congenital heart defects with various clinical presentations. The lifetime-risk of an individual living with AAOCA is unknown, and data from multicentre registries are urgently needed to adapt current recommendations and guide optimal patient management. The European Registry for AAOCA (EURO-AAOCA) aims to assess differences with regard to AAOCA management between centres.",[174,321,322,323,324,325,28,326],"Coronary Artery Anomaly","Sudden Cardiac Death","Surgical Procedure, Unspecified","Diagnosis","Arrhythmia","Adult Children",[328,329,330],"anomalous","coronary","sudden cardiac death","2023-10-11",{"date":333,"type":39},"2023-10-19",{"date":335,"type":39},"2019-01-01",{"date":337,"type":22},"2029-01-01",{"name":339,"class":46},"University of Padova",2,{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":11,"sex":17,"minAge":349,"maxAge":227,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":352,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":4},"100467682","phase-4-dex-vs-sevo-in-congenital-heart-surgery-100467682","NCT05369949","DEX vs SEVO in Congenital Heart Surgery","Effect of DEXmedetomidine and LOw Dose Sevoflurane on the Release of Serum Neurofilament Light in Congenital Cardiac Surgery.","DEXLOSNeuro","Inclusion Criteria:\n\n* Patients up to 3 years\n* Must undergo cardiac surgery with CPB\n\nExclusion Criteria:\n\n* Preoperative chronic kidney disease (glomerular filtration rate of less than 30 ml\u002Fmin per 1.73m2 for greater than 3 months)\n* Preoperative cerebral hemorrhage, stroke or\n* Preoperative seizures\n* Abnormal preoperative cerebral ultrasound\n* Preoperative Extracorporeal Life Support\n* Preoperative sedated and intubated patients\n* Preterm newborns (\\\u003C 32 W gestational age)\n* Newborns weighing \\\u003C 2 kg\n* Patients with Williams-Beuren syndrome.","1 Day",{"count":351,"type":22},150,[353],"PHASE4","Anesthesia-related neurotoxicity in the developing brain is still a concern although evidence in humans is debatable. Moreover, it is unclear whether repeated and\u002For prolonged exposures are harmless and whether their effects are more pronounced in newborns and infants with brains more vulnerable to injury. One such specific group of patients is children with congenital heart disease (CHD). Nearly, half of the school-age survivors with CHD exhibit neurodevelopmental symptoms. It is thus important to elucidate whether any plausible neurotoxicity of the commonly used anesthetic agents can be observed in this population, and whether specific neuroprotective strategies can be demonstrated within the frame of a randomized controlled trial (RCT).\n\nAnimal data have shown that dexmedetomidine (DEX) induces neuroprotective effects only at well-adjusted doses. One major issue with trials of anesthetic neurotoxicity is the latency between the conduct of these studies and the assessment of neurodevelopmental outcome. In contrast, the use of biomarkers of neuronal injury could be extremely valuable. Serum Neurofilament Light (NfL) has been shown to be a sensitive and specific marker of neuronal injury and is associated with neurologic outcome of children with various pathologies. The investigators hypothesize that in congenital heart surgery, use of DEX as main anesthetic agent in conjunction with low dose sevoflurane results in less release of serum NfL and is thus potentially less neurotoxic compared to the current standard of care. The hypothesis is tested with a RCT including patients between 0 - 3y undergoing surgery with cardiopulmonary bypass. To avoid any neurotoxicity due to anesthetic overdose, intraoperative burst suppression will be avoided. In addition to postoperative comparison of serum NfL, postoperative electroencephalogram and neurodevelopmental outcome of both groups will be compared taking into consideration the genetic background.",[28],"2022-09-20",{"date":358,"type":39},"2022-09-23",{"date":360,"type":22},"2023-01-05",{"date":362,"type":22},"2026-06-30",{"name":364,"class":46},"Cliniques universitaires Saint-Luc- Université Catholique de Louvain"]