[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"congenital-heart-disease-chd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:congenital-heart-disease-chd":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,44,75,105,138,164,186,210,236,263,282,311,334,363,392,414,437,466,493,515,537,557,583,604,627],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100640787","transition-and-transfer-of-congenital-heart-disease-care-from-pediatrics-to-adulthood-100640787",false,"NCT07585175","Transition and Transfer of Congenital Heart Disease Care From Pediatrics to Adulthood","Transition and Transfer of Congenital Heart Disease Care From Pediatrics to Adulthood.","Inclusion Criteria:\n\n* All new patients with congenital heart disease referred from the pediatric hospital and the community\n\nExclusion Criteria:\n\n* None","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","2 Years","OBSERVATIONAL","Adults with congenital heart disease (CHD) are a growing patient population in need of ongoing specialized care. Lapses in appropriate transition and transfer processes from childhood to adulthood in CHD care can lead to loss in follow up, late detection of new or evolving cardiac complications and negative patient outcomes. Therefore, it is vital that a robust transition and transfer process is established. Through a retrospective study completed recently at the University of Ottawa Heart Institute (UOHI) we have shown that the average wait time to be assessed by an adult congenital heart disease (ACHD) specialist is about 10 months and within this wait period 1 in 8 ACHD patients have a decline in their health.\n\nThe goal of this study is to specifically reduce negative patient outcomes during this wait period. We aim to achieve this by (i) establishing a program to ensure early detection of patients at risk of deterioration and (ii) providing additional support to these patients. The program is designed to have a multipronged approach including tools to disseminate concise patient specific information among care providers, maintain open line of communication with patients on the waitlist and promote patient education.\n\nWe plan to improve our transition care by creating a multi-pronged transfer program specifically for patients on the wait list composed of a nurse check in, creation of a diagnosis summary, education day and combined pediatric cardiology\u002FACHD handover videocall (described below). This program is planned as part of our care pathway and will be offered to all patients on the wait list. We intend to document the efficacy of this transition program to improve transition care by assessing patient reported outcomes and clinical outcomes of the patients who consent to complete additional questionnaires.\n\nThe multi-pronged program will include the following:\n\n1. ACHD nurse check-in (patient check-in via phone call or zoom from the ACHD nurse within 1 month of receiving referral) - allows early establishment of clinical relationship with the patient, screen for risk factors for deterioration and provision of ACHD clinic contact information to enable open line of communication. Patients considered at risk for deterioration on the wait-list based on this check-in conversation will be triaged for a more urgent first consult at the ACHD clinic.\n2. Quick glance diagnosis summary (Electronic on Epic MyChart) - will be created during nurse check in and will be used to disseminate concise patient specific information among health care workers and acts as a reference for the patients.\n3. Organization of an ACHD patient education day (half day hybrid event every 6 months) - allows formal introduction to the ACHD team, provides information session on ACHD care and lowers patients' threshold to inform the ACHD team in case of clinical deterioration.\n4. Combined pediatric cardiology and ACHD handover video call at time of transfer - allows effective and efficient handover of patient care from pediatric to adult care and facilitates the coordination of care during the transfer period.\n\nThese four components of the program work together to provide tools to disseminate concise patient specific information among care providers, maintain open line of communication with patients on the waitlist and promote patient education.",[26],"Congenital Heart Disease (CHD)",[28,29,30],"Adult Congenital Heart Disease","Transfer of care","Transition of care","RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":35},"2024-06-01",{"date":39,"type":21},"2026-12-31",{"name":41,"class":42},"Ottawa Heart Institute Research Corporation","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":18,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":43},"100635707","medlypeds-feasibility-study-100635707","NCT07556185","MedlyPeds Feasibility Study","MedlyPeds Feasibility Study: A Mobile, Smartdevice Based Telemonitoring for Pediatric Heart Disease, a Prospective Cohort Study","Inclusion Criteria:\n\n1. Consent provided.\n2. Aged 8-18 years of age.\n3. Ability to comply with using Medly (ex. able to stand on the weight scale, able to answer symptom questions, etc.)\n4. Followed at the Hospital for Sick Children Cardiology Clinic for any of the following reasons:\n\n   1. Heart failure of any etiology\n   2. Congenital heart disease\n   3. Acquired heart disease (eg. Kawasaki disease, rheumatic heart disease, connective tissue disorders etc)\n   4. Pulmonary hypertension\n   5. Post-cardiac surgery including heart transplant and ventricular assist devices\n\nExclusion Criteria:\n\n1. Unable to read or write in English.\n2. Participating in another clinical trial that may confound the results.\\* \\*Participant may be re-screened for eligibility at a later date.","8 Years",{"count":53,"type":21},30,"INTERVENTIONAL",[56],"NA","SickKids and UHN have developed MedlyPeds which is a smart phone application designed to remotely monitor patients with heart disease. This is a feasibility study which will enroll up to 30 patients with different types of heart disease to see which patient types may benefit the most from MedlyPeds if it were to be used for clinical monitoring. The study is gathering feedback about the app from patients, parents and clinicians to confirm how it needs to be modified to better serve the purpose in a future trial.",[59,26,60,61,62],"Pediatric Heart Failure","Acquired Heart Disease","Pulmonary Hypertension","Post Cardiac Surgery",[64,65],"Medly","Telemonitoring","2026-06-23",{"date":68,"type":35},"2026-06-26",{"date":70,"type":21},"2026-07",{"date":72,"type":21},"2029-12",{"name":74,"class":42},"The Hospital for Sick Children",{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":54,"phases":87,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":4},"100642186","the-effect-of-therapeutic-play-on-preoperative-anxiety-in-hospitalized-children-with-congenital-heart-disease-100642186","NCT07643168","The Effect of Therapeutic Play on Preoperative Anxiety in Hospitalized Children With Congenital Heart Disease","The Effect of Therapeutic Play on Preoperative Anxiety in Hospitalized Children With Congenital Heart Disease: A Randomized Controlled Trial","TP-CHD","Inclusion Criteria:\n\nChildren diagnosed with congenital heart disease via clinical and imaging examinations, scheduled for elective cardiac surgery (e.g., open-heart surgery under cardiopulmonary bypass, open chest device closure, or percutaneous interventional treatment).\n\n* Aged 0 to 12 years old, with basic communication and comprehension abilities to respond to play interventions and complete anxiety scale assessments.\n* Clear consciousness, no severe intellectual, hearing, or speech communication disorders, or pervasive developmental disorders (e.g., autism), and being able to interact with researchers.\n* Primary caregivers (father or mother) provide written informed consent and have the ability to understand the study and assist the child with the intervention.\n\nExclusion Criteria:\n\n* Children with complex critical CHD requiring emergency surgery or admission to the intensive care unit (ICU) upon hospitalization.\n* Children with severe neurological disorders (e.g., cerebral palsy, epilepsy), severe hepatic\u002Frenal insufficiency, or other major congenital diseases that may affect psychological status or perioperative progress.\n* Children who have taken sedatives, anxiolytics, or antidepressants long-term preoperatively, whose anxiety levels have been altered by medication.\n* Participants who cannot complete the intervention or outcome assessments for any reason (e.g., surgery cancellation, withdrawal of consent).","0 Years","12 Years",{"count":86,"type":21},204,[56],"Congenital Heart Disease (CHD) is the most common congenital malformation in children and the leading cause of death from birth defects in infancy. Preoperative anxiety is prevalent in children with CHD, but current preoperative care mainly focuses on physical preparation, with insufficient attention to psychological stress, and conventional intervention measures have limitations. As a non-pharmacological method, therapeutic play has been proven effective in relieving children's anxiety, but randomized controlled trials (RCTs) of therapeutic play for preoperative anxiety in children with CHD are still lacking in China. This study adopts a randomized controlled design, in which children with CHD before surgery are randomly divided into the experimental group and the control group. The experimental group receives therapeutic play (including parents' participation, with intervention content designed according to children's cognitive characteristics), while the control group receives routine preoperative nursing. The effect of therapeutic play on relieving preoperative anxiety in children with CHD will be evaluated multi-dimensionally through anxiety scale scores, vital signs, and salivary cortisol levels, providing scientific evidence for clinical intervention of preoperative anxiety in children with CHD.",[26],[91,92,93,94],"therapeutic play","anxiety","Congenital Heart Disease","pediatric patient","NOT_YET_RECRUITING","2026-06-09",{"date":98,"type":35},"2026-06-11",{"date":100,"type":21},"2026-06",{"date":102,"type":21},"2026-12",{"name":104,"class":42},"First Affiliated Hospital of Kunming Medical University",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":113,"maxAge":18,"enrollmentInfo":114,"targetDuration":4,"studyType":54,"phases":116,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100624107","effect-of-coughing-exercises-versus-incentive-spirometry-on-respiratory-function-and-recovery-in-children-after-cardiac-surgery-100624107","NCT07405333","Effect of Coughing Exercises Versus Incentive Spirometry on Respiratory Function and Recovery in Children After Cardiac Surgery.","Effect of Coughing Exercises Versus Incentive Spirometry on Respiratory Outcomes and Postoperative Recovery Among Children Undergoing Cardiac Surgery.","CEXIS","Inclusion Crit\n\n* Children aged 6 to 18 years scheduled for elective cardiac surgery.\n* Postoperative extubation within 24 hours and judged clinically stable to begin respiratory therapy.\n* Hemodynamically stable.\n\nExclusion Criteria:\n\n* Pre-existing moderate-to-severe chronic lung disease requiring baseline oxygen therapy.\n* Neuromuscular disorders significantly impairing cough\u002Finspiratory effort.\n* Emergency surgery, ongoing major bleeding.\n* Prolonged mechanical ventilation \\>72 hours or tracheostomy on admission.","6 Years",{"count":115,"type":21},99,[56],"This study examines the effects of coughing exercises and incentive spirometry (IS) on lung function and recovery in children who undergo heart surgery. The main goals are to see:\n\nHow coughing exercises and IS affect breathing and lung function after surgery? How these exercises influence overall recovery after surgery? Children who participate will be randomly assigned to one of three groups: coughing exercises, IS, or standard care. Those in the exercise groups will perform their assigned breathing exercises every 3 hours for the first 3 days after surgery. Daily check-ups will be conducted to monitor their progress, lung function, and oxygen levels.\n\nThe study will measure breathing ability, oxygen levels, and recovery milestones to find out which method is most effective in preventing lung complications and helping children recover faster.",[26,119,120],"Postoperative Respiratory Dysfunction","Postoperative Recovery After Cardiac Surgery",[122,123,93,124,125,126,127],"Coughing Exercises","Incentive Spirometry","Respiratory Function","Recovery","cardiac surgery","pediatric","2026-05-07",{"date":130,"type":35},"2026-05-12",{"date":132,"type":35},"2025-12-07",{"date":134,"type":21},"2026-10-07",{"name":136,"class":42},"University of Baghdad",4,{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":54,"phases":146,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":163},"100639006","bond-direct-breastfeeding-to-enhance-maternal-and-infant-health-in-congenital-heart-disease-100639006","NCT07582848","BOND: Direct Breastfeeding to Enhance Maternal and Infant Health in Congenital Heart Disease","Both mothers and infants are study participants.\n\nInclusion criteria:\n\n1. Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period.\n2. Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life.\n3. Admission to the ICU (either CICU or NICU) at participating center in 1st week of life and for whom cardiac surgical or transcatheter intervention is anticipated in the first 30 days of life.\n4. Willing to comply with protocol and provide written informed consent\n\nExclusion Criteria:\n\n1. Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation.\n2. Mother with a severe, untreated psychiatric condition, substance use disorder, or other circumstances that, in the opinion of the investigator, would interfere with engagement with study tasks or safe participation in the trial.\n3. Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent.\n4. Infant birthweight \\\u003C3rd percentile for gestational age\n5. Infant gestational age \\\u003C 36 weeks\n6. Infant with known genetic disorder likely to impact breastfeeding, such as trisomy 21 or cleft palate\n7. Medical condition or congenital anomaly that precludes safe direct breastfeeding for the infant as determined by investigator",{"count":145,"type":21},266,[56],"The primary objective of this study is to enhance the rates of direct breast feeding (DBF) among infants with congenital heart disease (CHD), and to gain insights into the implications of DBF on key metrics of child and parent well-being. A multicenter parallel cluster platform design will be employed. The intervention will be a multifaceted approach to enhance direct breastfeeding. Participating sites will be randomized into either intervention (strategies to enhance direct breastfeeding) or conventional care.",[26],[150,151,152,153],"Direct breastfeeding","CHD","Infant neurodevelopment","Maternal Mental Health","2026-05-06",{"date":156,"type":35},"2026-05-13",{"date":158,"type":21},"2026-04",{"date":160,"type":21},"2030-06",{"name":162,"class":42},"Carelon Research",8,{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":54,"phases":173,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":183,"leadSponsor":184,"locationsCount":185},"100639472","prenatally-initiated-psychological-intervention-for-mothers-of-infants-with-congenital-heart-disease-chd-100639472","NCT07582861","Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)","BOND HeartGPS: A Longitudinal Randomized Controlled Trial Examining the Maternal and Infant Effects of a Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)","Both mothers and infants are study participants.\n\nInclusion Criteria:\n\n1. Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period.\n2. Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life.\n3. CHD diagnosis received between 16.0 and 30.0 weeks gestation.\n4. Singleton pregnancy.\n5. Pregnant mother is planning to continue the pregnancy and pursue surgical or transcatheter intervention for the infant.\n\n5\\. Pregnant mother is able to participate and complete study assessments in English or Spanish.\n\nExclusion Criteria:\n\n1. Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation.\n2. Mother with a severe, untreated psychiatric condition, substance use disorder, or other circumstances that, in the opinion of the investigator, would interfere with engagement with study tasks or safe participation in the trial.\n3. Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent.\n4. Postnatal diagnosis of CHD.\n5. Fetus with a comorbid condition with a predictable and major impact on neurodevelopment (e.g., Trisomy 21, DiGeorge syndrome).\n6. Pregnant individual is aged \\\u003C18 years.\n7. Pregnant individual is carrying a surrogate pregnancy.\n8. Consented mother completes \\\u003C70% of survey questions at first (baseline) assessment.",{"count":172,"type":21},210,[56],"This is a two-arm, prospective, longitudinal, randomized controlled trial (RCT) that will compare usual care to usual care plus a prenatally initiated, virtually administered psychological intervention, called HeartGPS.",[26],[177,151,178,179,180],"HeartGPS","intervention","Parent mental health","Neurodevelopment",{"date":156,"type":35},{"date":158,"type":21},{"date":160,"type":21},{"name":162,"class":42},17,{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":17,"minAge":113,"maxAge":84,"enrollmentInfo":193,"targetDuration":4,"studyType":54,"phases":195,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":43},"100639548","adaptive-digital-exercise-rehabilitation-for-children-after-chd-surgery-100639548","NCT07574463","Adaptive Digital Exercise Rehabilitation for Children After CHD Surgery","Development and Evaluation of a Just-in-Time Adaptive Digital Exercise Rehabilitation Program for Children After Congenital Heart Disease Surgery","Inclusion Criteria:\n\n* Children aged 6 to 12 years\n* Diagnosed with congenital heart disease (CHD) and have undergone cardiac surgery\n* Clinically stable after transfer to the general ward, with stable circulatory, respiratory, musculoskeletal, and neurological status, and assessed by the clinician as suitable to begin active exercise rehabilitation\n* Able to understand and cooperate with basic exercise training requirements\n* Written informed consent provided by the child and the legally authorized guardian\n\nExclusion Criteria:\n\n* Absolute contraindications to exercise rehabilitation, including uncontrolled arrhythmia, acute heart failure, hemodynamic instability, severe aortic stenosis, acute myocarditis, or acute pericarditis\n* Severe comorbid conditions that could interfere with rehabilitation, including severe hepatic or renal dysfunction, malignancy, or acute infection\n* Musculoskeletal or neuromuscular disorders that would prevent participation in or completion of the rehabilitation training",{"count":194,"type":21},130,[56],"The goal of this clinical trial is to evaluate whether a Just-in-Time Adaptive Intervention (JITAI)-based digital exercise rehabilitation program can improve postoperative recovery in children after congenital heart disease (CHD) surgery. The study will examine whether this system can:\n\nImprove cardiopulmonary endurance, cardiac function, and muscle strength Increase rehabilitation adherence and enhance training experience while reducing exercise-related fear Researchers will compare children receiving the adaptive digital exercise rehabilitation program with those receiving standard postoperative rehabilitation to determine whether the digital program provides additional clinical and behavioral benefits.\n\nParticipants will:\n\nWear non-invasive monitoring devices to collect real-time physiological data Engage in daily structured exercise rehabilitation sessions guided by the digital system Receive adaptive adjustments in exercise intensity based on real-time physiological feedback Complete questionnaires on recovery, emotional status, and rehabilitation experience",[26,198],"Congenital Heart Disease in Children",[200],"Just-in-Time Adaptive Intervention","2026-05-05",{"date":203,"type":35},"2026-05-08",{"date":205,"type":21},"2026-12-30",{"date":207,"type":21},"2029-02-28",{"name":209,"class":42},"The Children's Hospital of Zhejiang University School of Medicine",{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":17,"minAge":218,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":54,"phases":222,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":4},"100636376","the-effect-of-music-and-musical-mobile-interventions-on-pain-and-physiological-parameters-100636376","NCT07564882","The Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters","The Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters During Chest Tube Removal in Infants Undergoing Congenital Heart Surgery","Music Pain Inf","Inclusion Criteria:\n\n* Infants aged 2 to 12 months\n* Undergoing surgery due to congenital heart disease\n* Having a single chest tube\n* Not receiving mechanical ventilation support\n* Parent(s) voluntarily agree to participate in the study\n\nExclusion Criteria:\n\n* Receiving mechanical ventilation support\n* Administration of analgesics within 2 hours prior to chest tube removal\n* Presence of a neurodevelopmental disorder\n* Parent(s) do not consent to participate in the study","2 Months","12 Months",{"count":221,"type":21},54,[56],"Chest tube removal in infants undergoing surgery for congenital heart disease is an invasive procedure associated with significant pain and physiological stress responses. This randomized controlled trial evaluates the effects of music and musical mobile interventions on pain and physiological parameters during chest tube removal. A total of 54 infants aged 2-12 months are randomly assigned to music, musical mobile, or control groups. Pain is assessed using the FLACC scale, and physiological parameters (heart rate and oxygen saturation \\[SpO₂\\]) are monitored. Measurements are obtained at predefined time points: periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal). The findings aim to support evidence-based non-pharmacological pain management in pediatric intensive care settings.",[26,225],"Chest Tube Removal",[225,227,93,228],"Nursing","Multisensory Distraction",{"date":203,"type":35},{"date":231,"type":21},"2026-04-30",{"date":233,"type":21},"2027-06-30",{"name":235,"class":42},"Baskent University",{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":17,"minAge":242,"maxAge":243,"enrollmentInfo":244,"targetDuration":4,"studyType":54,"phases":246,"briefSummary":247,"conditions":248,"keywords":249,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":163},"100601763","starlight-cardiovascular-lifeline-ductus-arteriosus-stent-ide-study-100601763","NCT07114718","Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study","Inclusion Criteria:\n\n1. Parental or legal authorized representative provide consent for study enrollment\n2. Infants \\\u003C 6 months of age\n3. Diagnosis of congenital heart defect with ductal-dependent pulmonary circulation requiring infusion of prostaglandins\n4. Requires ductus arteriosus stent diameters of 3.5mm or 4mm and stent lengths between 16mm and 28mm\n\nExclusion Criteria:\n\n1. Active blood stream infection\n2. Active or history of endocarditis\n3. Body weight \\\u003C2.5kg\n4. Gestational age \\\u003C32 weeks at birth\n5. Complete heart block\n6. Total Anomalous Pulmonary Venous Return\n7. Anatomic variation judged to be inappropriate for ductal stenting per the treating interventionalist\n8. Presence of an aortopulmonary collateral that is expected to require unifocalization\n9. Non-confluent pulmonary arteries (i.e. isolated pulmonary artery of ductal origin) or bilateral patent ductus arteriosus (PDA)\n10. Pulmonary atresia with intact ventricular septum with RV-dependent coronary circulation\n11. Currently participating in an investigational drug study or another device study that would confound the study results\n12. Patient who is on extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), or dialysis prior to ductal stenting procedure\n13. Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.)\n14. Patient who is undergoing another transcatheter procedure (e.g., atrial septostomy, aortic arch intervention, or right ventricular outflow tract intervention) during or within 24 hours prior to the ductus arteriosus stenting procedure\n15. Patient who, at the time of enrollment, is deemed not to be a candidate for eventual stage II palliation of single ventricle heart disease, complete surgical repair, nor transcatheter treatment with resultant biventricular circulation\n16. Patient who does not plan to return to the enrolling center or another participating center for stage II palliation, complete surgical repair, or definitive catheterization procedure\n17. Contraindications to peri-procedural anticoagulation\n18. Known to be non-responsive to aspirin or other antiplatelet therapies\n19. Known hypersensitivity or allergy to Nickel\n20. Known hypersensitivity to contrast media that cannot be adequately pre-medicated","1 Minute","6 Months",{"count":245,"type":21},35,[56],"Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the Lifeline Ductus Arteriosus Stent System. The study device is a stent that is designed to maintain patency of the Ductus Arteriosus for children who need blood flow through that part of the heart.",[93,26],[250,251,252],"Ductus Arteriosus Stent","pediatric stent","Lifeline Stent","2026-04-29",{"date":255,"type":35},"2026-05-01",{"date":257,"type":35},"2026-01-16",{"date":259,"type":21},"2028-04",{"name":261,"class":262},"Starlight Cardiovascular Inc","INDUSTRY",{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":43},"100581058","melody-registry-follow-up-study-100581058","NCT06845371","MELODY Registry Follow-Up Study","Inclusion Criteria:\n\n* previous inclusion in the MELODY Registry\n\nExclusion Criteria:\n\n* none",{"count":270,"type":21},845,"Extension of the MELODY Registry, to assess longterm follow-up clinical results of Melody valve implantation after its commercialization in Europe \u002F OUS",[26],"2026-04-28",{"date":275,"type":35},"2026-05-04",{"date":277,"type":35},"2026-04-01",{"date":279,"type":21},"2027-08-01",{"name":281,"class":42},"University Hospital Tuebingen",{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":291,"conditions":292,"keywords":294,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":43},"100634093","fontan-outcomes-in-oligemia-vs-plethora-in-univentricular-chd-100634093","NCT07535203","Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD","Comparison of Outcomes of Pulmonary Oligemia Versus Pulmonary Plethora in Cyanotic Congenital Heart Disease With Univentricular Heart After Fontan Procedure","Inclusion Criteria:\n\n* Diagnosed cyanotic CHD\n* Univentricular heart physiology\n* Planned staged palliation including Fontan procedure\n* Informed consent obtained (patient or guardian)\n\nExclusion Criteria:\n\n* Refusal to participate\n* Incomplete clinical data\n* Inability to complete follow-up",{"count":290,"type":21},52,"This prospective cohort study evaluates differences in clinical outcomes between pulmonary oligemia and pulmonary plethora in patients with cyanotic congenital heart disease and univentricular heart physiology undergoing staged palliation culminating in the Fontan procedure.Fifty-two patients will be classified into two groups based on pulmonary blood flow characteristics and followed for approximately 1.5 years after the Fontan procedure. Outcomes include mortality, morbidity, pulmonary hemodynamics, functional capacity, neurocognitive status, and quality of life.",[26,293],"Univentricular Heart",[295,296,297,298,299,300,301],"univentricular heart","congenital heart disease","fontan procedure","pulmonary blood flow","oligemia","plethora","pulmonary hemodynamics","2026-04-14",{"date":304,"type":35},"2026-04-17",{"date":306,"type":35},"2025-01-01",{"date":308,"type":21},"2027-06",{"name":310,"class":42},"Sisca Natalia Siagian",{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":318,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":43},"100621821","a-multimodal-ai-prediction-model-for-complications-after-transcatheter-closure-of-perimembranous-vsd-in-children-100621821","NCT07375602","A Multimodal AI Prediction Model for Complications After Transcatheter Closure of Perimembranous VSD in Children","Multimodal Clinical Data Integration and Artificial Intelligence Modeling for Predicting Complications Following Pediatric Transcatheter Closure of Perimembranous Ventricular Septal Defect","Inclusion Criteria:\n\n* Age ≤ 18 years at the time of transcatheter procedure.\n* Diagnosis of perimembranous ventricular septal defect confirmed by echocardiography, and underwent transcatheter device closure at the study center.\n* Medical records sufficient to ascertain the primary outcome within the pre-specified follow-up window, and availability of minimum baseline clinical information required for model development\u002Fvalidation.\n\nExclusion Criteria:\n\n* Ventricular septal defects not classified as perimembranous on echocardiography, including muscular, outlet, or inlet VSDs, as well as multiple or complex VSDs involving more than one septal region.\n* Presence of complex congenital heart disease or associated structural abnormalities requiring concomitant surgical repair (e.g., tetralogy of Fallot).\n* Prior surgical VSD repair or prior transcatheter VSD closure.",{"count":319,"type":21},5249,"The goal of this observational study is to develop and validate a multimodal artificial intelligence prediction model for treatment-related complications in children with perimembranous ventricular septal defect (pmVSD) undergoing transcatheter device closure. The main question it aims to answer is: Can an AI model that integrates demographics, laboratory results, electronic health record text, echocardiography reports, chest radiographs, and electrocardiogram accurately predict the risk of complications at the individual patient level? Data will be retrospectively collected from routine clinical care records of pediatric patients who underwent transcatheter closure for pmVSD. Deep learning methods will be used to extract features from text and images to train and validate the prediction model.",[26,322,323,324],"Ventricular Septal Defects (VSD)","Cardiac Catheterization","Postoperative Complications","2026-04-03",{"date":327,"type":35},"2026-04-09",{"date":329,"type":35},"2026-02-01",{"date":331,"type":21},"2026-06-15",{"name":333,"class":42},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":54,"phases":344,"briefSummary":346,"conditions":347,"keywords":350,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":4},"100631294","phase-2-sota-es---sotatercept-in-patients-with-congenital-heart-disease-and-eisenmengers-syndrome-100631294","NCT07498803","Sota-ES - Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome","Sota-ES - A Prospective, Non-randomized, Open-label, Multi-center Study of the Activin Signaling Inhibitor Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome","CHASE","Inclusion Criteria:\n\n* Age ≥18 years\n* Congenital heart disease with Eisenmenger syndrome (known unrepaired atrial septal defect, and\u002For ventricular septal defect, and\u002For patent ductus arteriosus; patients with anomalous pulmonary venous drainage will not be considered)\n* Eisenmenger syndrome defined as right-to-left or bi-directional shunt with a mPAP \\>25 mmHg, PAWP \\\u003C 15 mmHg, and PVR \\>5 WU\n* In patients with pre-tricuspid shunt, the consideration of Eisenmenger syndrome requires one of the following: Systemic arterial O2 saturation (SaO2) at rest \\\u003C88% and more than 70%, and\u002For SaO2 \\\u003C80% during 6MWT, and secondary erythrocytosis (Hb \\> 15.0 g\u002Fdl for females and 16.0 g\u002Fdl for males)\n* On stable doses of background PAH therapy\\* and diuretics (i.e., patient-individual dose goal for each therapy achieved) for ≥30 days\n* 6-minute walking distance \\>100 m\n* WHO-FC II or III\n* Written informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n\n  * Diagnosis of pulmonary hypertension groups 2, 3, 4, or 5\n  * Hospitalization or change in PAH background therapies within 30 days prior to screening (changes in dose of diuretics or parenteral prostanoids \\[\\\u003C10% change in infusion rate over the preceding 3 months\\] are allowed)\n  * Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \\>160 mmHg or sitting diastolic blood pressure \\>100 mmHg during screening visit after a period of rest\n  * Baseline systolic blood pressure \\\u003C90 mmHg at screening\n  * Left ventricular systolic dysfunction (LVEF 40%)\n  * Restrictive lung disease with a TLC \\\u003C 60% AND demonstration of more than mild fibrosis on chest CT prior to enrolment (note that patients with congenital heart disease may have thoracic cage deformities \\[e.g. pectus\\] that may lead to thoracic cage restriction in the absence of parenchymal lung disease).\n  * Obstructive lung disease (FEV1 \\\u003C 60% pred. and FEV1\u002FFVC \\\u003C60%)\n  * Chronic thromboembolic disease (intermediate or high probability) on V\u002FQ scan and evidence of distal thromboembolism on CT angiography (note that proximal in-situ thrombosis is a known complication of Eisenmenger's and will not be considered an exclusion criterion - such patients may be reviewed centrally for inclusion)\n  * Significant liver disease (Child II or III)\n  * Any of the following clinical laboratory values at the screening visit:\n\n    * Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002Fm2 (as defined by the Modification of Diet in Renal Disease \\[MDRD\\] equation)\n    * Serum alanine aminotransferase, aspartate aminotransferase, or total bilirubin levels \\>3 × ULN (bilirubin criterion waived if there is a documented history of Gilbert's syndrome)\n  * Baseline platelet count \\\u003C50,000\u002Fµl (\\\u003C50.0 x 109\u002FL) at screening\n  * Documented episodes of previous repetitive hyperviscosity syndrome\n  * History of haemoptysis within 12 months prior to screening, and\u002For repeated severe epistaxis (≥ 1 episode per month)\n  * Uncorrected iron deficiency (iron stores must be normal defined as a Ferritin \\> 100 and transferrin saturation \\[TSAT\\] ≥ 20%)\n  * Recent (\\\u003C 3 months) enrolment into a rehabilitation program\n  * Untreated sleep disordered breathing with an AHI \\> 10. Patients with sleep apnea will need to have been on CPAP or BiPAP for 3 months prior to enrolment.\n  * Prior or current exposure to sotatercept or luspatercept\n  * Treatment by phlebotomy within 1 month prior to screening\n  * Participation in another interventional study\n  * Pregnant (serum B-HCG) or lactating women",{"count":343,"type":21},40,[345],"PHASE2","The present study seeks to provide pilot data on the safety and efficacy of medical therapy with sotatercept in patients with an established diagnosis of congenital heart disease and Eisenmenger syndrome.\n\nCHASE is an interventional, single-arm, open-label study, that will enroll 40 patients with an established diagnosis of CHD and Eisenmenger syndrome. PAH background therapy may be present at the discretion of the investigators at the time of enrolment. CHASE will be performed only in countries where standard PAH therapies are available and reimbursed. At the end of the 24-week patient period, PAH treatment is left to the investigator's discretion.",[26,348,349],"Eisenmenger Syndrome","PAH",[351,352,353],"Congenital heart disease with Eisenmenger syndrome","WHO-FC II or III","PAH therapy","2026-03-23",{"date":356,"type":35},"2026-03-27",{"date":358,"type":21},"2026-09-01",{"date":360,"type":21},"2028-12-31",{"name":362,"class":42},"Philipps University Marburg",{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":17,"minAge":371,"maxAge":372,"enrollmentInfo":373,"targetDuration":4,"studyType":54,"phases":375,"briefSummary":377,"conditions":378,"keywords":379,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":390,"locationsCount":43},"100583933","phase-1-butyric-acid-supplementation-for-gut-improvement-after-cardiac-surgery-in-kids-100583933","NCT06882772","Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids","Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids, A Phase IIa Clinical Trial","BASICS-Kids","Inclusion Criteria:\n\n* Infants and Children undergoing cardiac surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Antibiotics, surgery, or chemotherapy within the past 8 weeks\n* Continuous enteral feeds before surgery\n* GI pathology or intestinal surgery (excluding G-tube)\n* Liver disease with elevated transaminitis or dialysis-dependent renal disease","1 Month","3 Years",{"count":374,"type":21},105,[376,345],"PHASE1","Butyric acid has been shown to promote gut health and improve the microbiome in multiple adult studies. In preliminary studies in older children with inflammatory bowel disease, butyric acid was shown to be safe. However, it's suitability for infants and young children with congenital heart disease (CHD) has yet to be determined.\n\nThis study will examine butyric acid supplementation in infants and children, ages 1 month to 3 years, with CHD who require cardiac surgery with cardiopulmonary bypass. Study goals include determining the safety and tolerability of butyric acid supplementation before cardiac surgery, and to identify changes in gut microbial communities, metabolic profile, and genetic markers intestinal function. Also, the study seeks to establish a reduction in inflammation (inflammatory signaling) after cardiopulmonary bypass (CPB) in participants receiving butyric acid.",[26],[93,380,381,382,383],"Gut Health","Microbiome","Gut Barrier Function","Inflammation","2026-02-21",{"date":386,"type":35},"2026-02-24",{"date":388,"type":21},"2026-03",{"date":72,"type":21},{"name":391,"class":42},"University of Nebraska",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":17,"minAge":371,"maxAge":22,"enrollmentInfo":400,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":413},"100621688","growth-in-infants-with-congenital-heart-disease-at-auch-100621688","NCT07373873","Growth in Infants With Congenital Heart Disease at AUCH","Assessment of Growth in Children With Congenital Heart Disease in Assuit University Children Hospital","CHD-Growth","Inclusion Criteria:\n\n* Children aged 1 month to 2 years.\n* Diagnosis of congenital heart disease (CHD) confirmed by echocardiography.\n* Availability of anthropometric data in the medical record.\n\nExclusion Criteria:\n\n* Presence of a known genetic syndrome or major extracardiac anomalies.\n* Pre-existing endocrine or metabolic disorder affecting growth.\n* Preterm birth (gestational age \\\u003C37 weeks).\n* Previous surgical\u002Finterventional procedure for CHD.",{"count":401,"type":21},72,"Children with congenital heart disease (CHD) often experience growth problems. This study aims to assess and compare the growth (weight, height, head circumference) of infants and children with CHD against the expected growth standards for healthy children. This is a retrospective study that will review the medical records of children aged 1 month to 2 years who were diagnosed with CHD at Assiut University Children Hospital. The study will help understand how different types of CHD affect a child's growth, which is important for improving their nutritional care and overall management.",[26],"2026-01-23",{"date":406,"type":35},"2026-01-28",{"date":408,"type":21},"2026-03-01",{"date":410,"type":21},"2027-05-01",{"name":412,"class":42},"Assiut University",2,{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":17,"minAge":371,"maxAge":18,"enrollmentInfo":421,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":423,"conditions":424,"keywords":426,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":4},"100608665","chromosomal-abnormalities-in-patients-with-congenital-heart-disease-at-assiut-university-childrens-hospital-100608665","NCT07204509","Chromosomal Abnormalities in Patients With Congenital Heart Disease at Assiut University Children's Hospital","Incidence of Chromosomal Abnormalities in Patients With Congenital Heart Diseases Attending Assiut University Children's Hospital","Inclusion Criteria:\n\n* Children with a confirmed diagnosis of congenital heart disease (by echocardiography and\u002For cardiology evaluation).\n* Age between 1 month and 18 years.\n* Patients attending Assiut University Children's Hospital or Elmabara Insurance Hospital during the study period.\n* Informed consent obtained from parents or legal guardians.\n\nExclusion Criteria:\n\n* Patients with acquired (non-congenital) heart disease.\n* Critically ill patients in unstable condition not suitable for blood sampling.\n* Incomplete clinical data or refusal of parents\u002Fguardians to participate.",{"count":422,"type":21},138,"Congenital heart disease (CHD) is one of the most common birth defects and an important cause of infant morbidity and mortality. Many children with CHD also have underlying genetic abnormalities, particularly chromosomal abnormalities, which may affect their prognosis, management, and counseling. This study aims to determine the incidence and pattern of chromosomal abnormalities among children with CHD attending Assiut University Children's Hospital and Elmabara Insurance Hospital.\n\nChildren with a confirmed diagnosis of CHD will undergo a detailed clinical assessment, including dysmorphic evaluation, followed by chromosomal analysis (karyotyping). The study will help identify the frequency and type of chromosomal abnormalities associated with CHD and their correlation with specific cardiac defects and phenotypic features.\n\nUnderstanding these genetic associations may improve diagnosis, early intervention, and family counseling, and provide useful information for risk stratification and prevention strategies in the Egyptian population.",[26,425],"Chromosomal Abnormalities",[427,428],"Karyotyping","gentic disease","2025-09-25",{"date":431,"type":35},"2025-10-02",{"date":433,"type":21},"2025-10-01",{"date":435,"type":21},"2026-12-01",{"name":412,"class":42},{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":17,"minAge":445,"maxAge":446,"enrollmentInfo":447,"targetDuration":4,"studyType":54,"phases":449,"briefSummary":450,"conditions":451,"keywords":452,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":465},"100527876","cord-clamping-among-neonates-with-congenital-heart-disease-100527876","NCT06153459","Cord Clamping Among Neonates With Congenital Heart Disease","CORD-CHD: Clamp OR Delay Among Neonates With Congenital Heart Disease","CORD-CHD","Inclusion criteria are listed below and will be confirmed prior to randomization:\n\n1. Fetal diagnosis of congenital heart disease (CHD) by prenatal ultrasound \u002F echocardiography from local fetal ECHO, conducted on or after 18 weeks of gestation and prior to randomization. The study fetal diagnosis of CHD must be rated as 3 - 6 on the Fetal Cardiovascular Disease Severity Score (FCDSS), as determined by independent evaluators at the CORD-CHD trial ECHO Core at the Children's Hospital of Philadelphia (to determine final FCDSS eligibility for randomization).\n\n   For each potential participant that has provided consent, the most relevant diagnostic prenatal ultrasound will be uploaded (shared) between 32 weeks of gestation and randomization for review by the ECHO Core. The ECHO Core will make the final FCDSS determination for eligibility status and stratification assignment.\\]\n\n   \\[NOTE: A fetal diagnosis of CHD rated as 3 - 6 FCDSS per local review, including borderline cases, will be used to determine preliminary eligibility for consent. Among borderline cases, eligible patients will be included if there is a reasonable expectation of the need for surgery or cardiac catheterization during the birth hospitalization.\\]\n2. Singleton gestation.\n3. Gestational age at randomization for impending deliveries between 37 0\u002F7 - 41 6\u002F7 weeks of gestation inclusive based on clinical information and evaluation of the earliest ultrasound determined using criteria proposed by the American Congress of Obstetricians and Gynecologists (ACOG), the American Institute of Ultrasound in Medicine and the Society for Maternal-Fetal Medicine.\n\n   \\[NOTE: Pregnant individuals who were admitted to the delivery hospital prior to 37 0\u002F7 weeks of gestation remain eligible to randomize, provided they deliver within the 37 0\u002F7 and 41 6\u002F7 weeks \"eligibility window\". Alternatively, if an eligible dyad is randomized at or just prior to 41 6\u002F7 weeks, they remain in trial.\\]\n4. Consent for the participant and their infant\n\nExclusion criteria are listed below and will be confirmed prior to randomization:\n\nExclusion Criteria for Pregnant Individuals:\n\n1. Pregnant individual is a gestational carrier or surrogate.\n2. Compromise of the pregnant individual (e.g., vasa previa, placental accreta with hypotension, placental abruption, amniotic fluid embolism, uterine rupture, uterine inversion, disseminated intravascular coagulation), as determined by local care team\n\n\\[NOTE: There is no limitation on pregnant individual's age\\]\n\nFetal Exclusion Criteria:\n\n1. Fetal demise or planned termination of pregnancy prior to randomization\n2. Tachyarrhythmia requiring transplacental therapy\n3. Fetal hydrops, severe\n4. Planned fetal surgery\n5. Diaphragmatic hernia, omphalocele, gastroschisis, intestinal atresia\n6. Major chromosomal defects (e.g., Trisomy 13, 18) identified prenatally; Trisomy 21 is allowed\n7. Disease or disorder impacting candidacy for neonatal cardiac interventions\n8. Parents choosing to limit treatment\n\nPregnancy Exclusion Criteria:\n\n1. Delivery planned at an institution not affiliated with or does not refer to a CORD-CHD participating site\n2. Participation in another prenatal interventional study that influences cord clamping or perinatal morbidity or mortality","37 Weeks","42 Weeks",{"count":448,"type":21},500,[56],"The goal of this clinical trial is to compare 2 different timepoints for clamping the umbilical cord at birth for term-born infants with a prenatal diagnosis of congenital heart disease (CHD). The main questions it aims to answer are:\n\n* Does Delayed Cord Clamping at 120 seconds (DCC-120) or Delayed Cord Clamping at 30 seconds (DCC-30) after birth lead to better health outcomes?\n* Does DCC-120 seconds or DCC-30 seconds after birth lead to better neuromotor outcomes at 22-26 months of infant age (postnatal)?\n\nParticipants will be asked to do the following:\n\n* Participate in either DCC-120 or DCC-30 at birth (randomized assignment).\n* Complete General Movements Assessment (GMA) at 3-4 months of infant age (postnatal), complete questionnaires \u002F surveys at this time.\n* Complete questionnaires \u002F surveys at 9-12 months of infant age (postnatal).\n* Complete Hammersmith Infant Neurological Examination (HINE), Developmental Assessment of Young Children 2 Edition (DAYC-2), and questionnaires \u002F surveys at 22-26 months of infant age (postnatal).\n* Permit data collection from electronic medical records for both the mother and infant study participants.\n\nInvestigators will compare DCC-120 vs. DCC-30 to see which approach is more beneficial to both the mother and baby with CHD.",[26],[453,454,455,443],"cord clamping","echocardiography (ECHO)","congenital heart disease (CHD)","2025-07-31",{"date":458,"type":35},"2025-08-05",{"date":460,"type":35},"2023-12-19",{"date":462,"type":21},"2030-12",{"name":464,"class":42},"Carl Backes, MD",21,{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":17,"minAge":372,"maxAge":472,"enrollmentInfo":473,"targetDuration":4,"studyType":54,"phases":475,"briefSummary":476,"conditions":477,"keywords":480,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":4},"100597196","feasibility-study-of-home-cardiac-rehabilitation-program-for-postoperative-children-with-congenital-heart-disease-100597196","NCT07055347","Feasibility Study of Home Cardiac Rehabilitation Program for Postoperative Children With Congenital Heart Disease","Children With Congenital Heart Disease After Surgery\n\nInclusion Criteria:\n\n* Meet the diagnostic criteria for congenital heart disease\n* Aged between 3 and 7 years\n* Underwent open-heart congenital heart disease correction surgery at the research institution and achieved correction in a single surgery\n* Have been discharged after completing inpatient postoperative rehabilitation\n* Able to communicate in Chinese\n\nExclusion Criteria:\n\n* Postoperative arrhythmia\n* Neurological, respiratory, or other comorbid diseases in addition to congenital heart disease and assessed by a physician as unsuitable for exercise\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* The primary caregiver of the child, limited to the child's father or mother\n* Among parents, the one who has provided care for the longest duration\n* Able to communicate in Chinese\n\nExclusion Criteria:\n\n* Caregivers of children who voluntarily discontinued treatment before its completion\n* Paid or non-parental caregivers\n* Individuals with diagnosed cognitive impairment or mental illness\n* Inability to communicate effectively through spoken language\n* Serious conflict or instability in the caregiver-child relationship\n* Inability to independently operate and use smart electronic devices and internet-based tools","9 Years",{"count":474,"type":21},5,[56],"This single-arm feasibility study will pilot a home-based cardiac rehabilitation program for preschool children (aged 3 to 7 years) who have undergone corrective surgery for congenital heart disease. Following the development of the program through expert consensus, this phase will implement the preliminary version of the program in a selected sample of caregiver-child pairs over a 12-week period. The study will assess feasibility by evaluating caregiver adherence to the intervention, acceptability of the program components, and completeness of rehabilitation task records. Descriptive data on safety, participation rate, and delivery logistics will also be collected. Findings will inform refinement of the program prior to future effectiveness testing.",[26,478,479],"Preschool Children","Rehabilitation",[93,481,482,483],"preschool children","Postoperative heart rehabilitation","Home rehabilitation","2025-06-27",{"date":486,"type":35},"2025-07-08",{"date":488,"type":21},"2025-08-01",{"date":490,"type":21},"2026-02-20",{"name":492,"class":42},"Sun Yat-sen University",{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":502,"conditions":503,"keywords":505,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":43},"100561304","clinical-readiness-skin-punch-biopsy-sample-collections-100561304","NCT06588426","Clinical Readiness Skin Punch Biopsy Sample Collections","Clinical Readiness Skin Punch Biopsy Sample Collection","Inclusion Criteria:\n\n* Age 18 and older\n* Congenital heart disease\n* Likely to qualify for an active clinical trial under IND 28611 in the future\n\nExclusion Criteria:\n\n* Previous cardiac transplantation\n* Unable or unwilling to consent\n* HIV diagnosis\n* Hepatitis diagnosis",{"count":501,"type":21},100,"This is a clinical readiness skin punch biopsy sample collection study. This will allow to reduce manufacturing time when patients are identified as eligible to receive product under separate interventional treatment protocol.",[26,504],"Congenital Heart Defect",[151,504],"2025-06-23",{"date":508,"type":35},"2025-06-25",{"date":510,"type":35},"2024-09-13",{"date":512,"type":21},"2027-07",{"name":514,"class":42},"HeartWorks, Inc.",{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":17,"minAge":113,"maxAge":84,"enrollmentInfo":522,"targetDuration":4,"studyType":54,"phases":524,"briefSummary":525,"conditions":526,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":535,"locationsCount":43},"100583677","preoperative-sleep-intervention-on-postoperative-delirium-in-school-aged-children-undergoing-congenital-heart-surgery-100583677","NCT06879431","Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery","The Impact of Cognitive Behavioral Intervention On Postoperative Delirium In School-aged Children With Sleep Disorder Undergoing Congenital Heart Surgery: A Multicenter, Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Age 0-36 months\n2. Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.\n3. Sleep disorder assessed by Children's Sleep Habits Questionnaire (CSHQ) (CSHQ score \\>48)\n\nExclusion Criteria:\n\n1. Preoperative use of sleep therapy-related medications\n2. The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4\n3. History of preoperative cardiac assist device, mechanical ventilation support, or asphyxia rescue\n4. Emergency surgery or preoperative ICU admission\n5. History of neurodevelopmental disorders such as autism spectrum disorder, attention deficit hyperactivity disorder, or psychiatric disorders such as depression\n6. Combined severe hepatic and renal dysfunction\n7. Combination of non-cardiac malformations (adenoid hypertrophy, tracheobronchial stenosis, polysplenism, anaplastic syndrome, Down syndrome, DiGeoge syndrome, diabetes mellitus, reproductive system abnormalities, anal atresia and Williams syndrome, eye disorders)\n8. History of preoperative cerebral ischemia and hypoxia\n9. Concurrent participation in other clinical trials\n10. Refusal of the family to sign the informed consent form or poor compliance by the child",{"count":523,"type":21},544,[56],"This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in sleep-disordered school-aged children undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Children's Sleep Habits Questionnaire (CSHQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received a short intensive cognitive-behavioral intervention 7-14 days before surgery, and no intervention was imposed on the control group. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.",[527,528,26],"Delirium - Postoperative","Sleep Problems","2025-05-27",{"date":531,"type":35},"2025-05-31",{"date":533,"type":35},"2025-04-28",{"date":39,"type":21},{"name":536,"class":42},"Yan Fuxia",{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":17,"minAge":544,"maxAge":372,"enrollmentInfo":545,"targetDuration":4,"studyType":54,"phases":547,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":556,"locationsCount":43},"100582337","preoperative-sleep-intervention-on-postoperative-delirium-in-infants-and-toddlers-undergoing-congenital-heart-surgery-100582337","NCT06861998","Preoperative Sleep Intervention on Postoperative Delirium in Infants and Toddlers Undergoing Congenital Heart Surgery","The Impact of Behavioral Intervention On Postoperative Delirium In Sleep-Disordered Infants and Toddlers Undergoing Congenital Heart Surgery: A Multicenter, Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Age 0-3 years\n2. Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.\n3. Children with sleep disorders who are screened by the Brief Infant Sleep Questionnaire-Revised short form (BISQ-R SF).\n\nExclusion Criteria:\n\n1. Infants and toddlers who have taken any relevant preoperative treatment for sleep problems\n2. The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4.\n3. Preoperative history of cerebral ischemia and hypoxia, developmental disorders such as autism spectrum disorders, etc.\n4. Presence of any other preoperative acute or chronic medical condition (mechanical ventilation support, history of asphyxia rescue, severe hepatic or renal dysfunction, or comorbidities with other non-cardiac malformations)\n5. Concurrent participation in other clinical trials\n6. Refusal of the family to sign the informed consent or poor compliance of the child.","1 Day",{"count":546,"type":21},452,[56],"This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in sleep-disordered infants and toddlers undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Brief Infant Sleep Questionnaire (BISQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received sleep hygiene education and a bedtime routine based on touch, the control group received only sleep hygiene education. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, and secondary outcomes include postoperative sleep quality, pain score, perioperative organ injury (including AKI, acute lung injury, and postoperative liver dysfunction), clinical recovery and prognosis. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.",[527,528,26],"2025-05-24",{"date":552,"type":35},"2025-05-28",{"date":554,"type":35},"2025-04-30",{"date":39,"type":21},{"name":536,"class":42},{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":18,"enrollmentInfo":564,"targetDuration":4,"studyType":54,"phases":566,"briefSummary":567,"conditions":568,"keywords":570,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":579,"leadSponsor":581,"locationsCount":43},"100586210","community-based-remote-cardiac-rehabilitation-program-for-pediatric-patients-with-complex-congenital-heart-disease-100586210","NCT06912412","Community-Based Remote Cardiac Rehabilitation Program for Pediatric Patients With Complex Congenital Heart Disease","Development and Validation of a Community-Based Remote Cardiac Rehabilitation Program for Improving Cardiopulmonary Function and Quality of Life in Pediatric Patients With Complex Congenital Heart Disease","Inclusion Criteria:\n\n1. Aged between 8 and 18 years\n2. Diagnosed with complex congenital heart disease (Complex CHD) and have undergone surgery\n3. At least 3 months post-cardiac surgery with a stable hemodynamic status\n4. Capable of using remote programs (e.g., mobile apps, video-conferencing platforms) at home, with technical support from a caregiver\n5. Either the participant or their caregiver agrees to study participation and has signed the informed consent form\n\nExclusion Criteria:\n\n1. Patients with uncontrolled arrhythmias, acute heart failure, myocarditis, pericarditis, or other ongoing cardiovascular conditions.\n2. Patients who are unable to exercise independently due to neurological or musculoskeletal disorders.\n3. Patients who cannot understand or carry out remote rehabilitation program instructions due to cognitive impairment.\n4. Patients showing clinically significant levels of depression or anxiety on the CDI-2 or RCMAS.\n5. Patients who cannot cooperate with required study assessments (e.g., CPET, ECG, 6MWT).",{"count":565,"type":21},10,[56],"This study is to develop a 12-week community-based remote cardiac rehabilitation program for pediatric patients with complex congenital heart disease and to assess its validity and safety.\n\nFor these children, a multidisciplinary approach including pediatric rehabilitation medicine, pediatric thoracic surgery, pediatrics, pediatric psychiatry, sports science, and nutrition is essential, but such comprehensive services are rarely available in Korea. As a result, pediatric cardiac rehabilitation at the community level is nearly nonexistent. Recent long-term retrospective cohort studies suggest that maintaining regular physical activity and aerobic capacity from early childhood significantly reduces future cardiovascular complications, emphasizing the importance of early pediatric cardiac rehabilitation. However, participation in existing programs is low due to limited accessibility.\n\nThe investigators hypothesize that a community-based remote cardiac rehabilitation program for these patients is both valid and safe. Participants will be children aged 8-18 years diagnosed with complex congenital heart disease , at least 3 months post-surgery, and stable cardiovascular status.\n\nInterventions include supervised and self-directed cardiac rehabilitation exercises. Monitoring (heart rate, SpO2, ECG) will be performed in real-time, with non-real-time data collection of physical activity using smartwatches. The intervention lasts 12 weeks with a 12-week follow-up.\n\nValidity measures include baseline evaluation, adherence, dropout rate, participant and parent satisfaction, and changes in cardiopulmonary exercise capacity, physical activity, body composition, fitness (6-minute walk, strength, flexibility, respiratory muscle strength), and questionnaires (physical activity, quality of life, exercise satisfaction, depression, psychological state).\n\nSafety will be assessed by monitoring adverse events, vital signs, fatigue (Borg scale), and pain before and after exercise.",[26,569,198],"Complex Congenital Heart Disease",[571,572,573,574],"Complex congenital heart disease","remote cardiac rehabilitation","cardiac rehabilitation","children cardiac rehabilitation","2025-03-30",{"date":577,"type":35},"2025-04-04",{"date":531,"type":21},{"date":580,"type":21},"2029-12-31",{"name":582,"class":42},"Seoul National University Hospital",{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":589,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":591,"conditions":592,"keywords":593,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":603},"100584128","construction-of-a-multi-center-clinical-research-collaboration-network-for-children-with-congenital-heart-disease-in-china-100584128","NCT06885307","Construction of a Multi-center Clinical Research Collaboration Network for Children with Congenital Heart Disease in China","Inclusion Criteria:\n\n1. Age 0-18 years, regardless of gender;\n2. Patients diagnosed with congenital heart disease confirmed by cardiac ultrasound examination;\n\nExclusion Criteria:\n\nNone",{"count":590,"type":21},35000,"This project intends to unite the representatives of typical congenital heart disease hospitals in various provinces and cities across the country to jointly establish a multi-center clinical research collaboration network for children with congenital heart disease in China, establish a platform and mechanism for the collection and sharing of data on children with congenital heart disease in China, and create a real-world public database of children with congenital heart disease in China that benchmarks the international level, so as to provide a solid data foundation for high-quality research on children with congenital heart disease in China.",[26],[26,594],"Database","2025-03-19",{"date":597,"type":35},"2025-03-20",{"date":599,"type":35},"2019-06-01",{"date":601,"type":21},"2025-12-30",{"name":333,"class":42},6,{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":610,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":612,"enrollmentInfo":613,"targetDuration":4,"studyType":54,"phases":615,"briefSummary":616,"conditions":617,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":4},"100576772","impact-of-vitamin-c-supplementation-on-hospital-outcomes-in-children-undergoing-corrective-heart-surgery-for-congenital-heart-diseases-100576772","NCT06789640","Impact of Vitamin C Supplementation on Hospital Outcomes in Children Undergoing Corrective Heart Surgery for Congenital Heart Diseases","Impact of Vitamin C Supplementation on the Hospital Outcomes in Children Undergoing Corrective Heart Surgery for Congenital Heart Diseases","RCT","Inclusion Criteria:\n\n* Children in the first two years who will be for corrective surgery for heart diseases congenital heart diseases\n* Pediatric patients whose parents or caregivers agree to be enrolled in the study.\n* Risk Adjustment for Congenital Heart Surgery -1 (RACHS-1) for Evaluation of Mortality in Children Undergoing Cardiac Surgery : the first two categories (Thiagarajan and C. Laussen 2015)\n\nExclusion Criteria:\n\n* Pediatric patients with associated comorbid conditions.","7 Years",{"count":614,"type":21},20,[56],"Vitamin C will be given before admission in the immediate preoperative preceding 7 days (the dose 30 -45 mg per day ) in oral drops preparations\n\nInflammatory markers including CRP , TLC ,PNI , GPS NLR will be checked on admission and on discharge and compared between cases and controls Hospital length stay will also be compared between the two groups",[26],"2025-02-13",{"date":620,"type":35},"2025-02-17",{"date":622,"type":21},"2025-02-19",{"date":624,"type":21},"2025-04-19",{"name":626,"class":42},"Cairo University",{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":4,"eligibilityCriteria":633,"healthyVolunteers":634,"sex":635,"minAge":4,"maxAge":4,"enrollmentInfo":636,"targetDuration":638,"studyType":23,"phases":4,"briefSummary":639,"conditions":640,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":43},"100577271","a-multicenter-study-of-artificial-intelligence-model-for-fetal-congenital-heart-disease-100577271","NCT06796127","A Multicenter Study of Artificial Intelligence Model for Fetal Congenital Heart Disease","Beijing Anzhen Hospital","Inclusion Criteria:\n\n* Single or multiple pregnancy;\n* Gestational age 16-40 weeks;\n* Fetal echocardiographic images are clear and complete;\n* Clinical data are complete and detailed;\n* Sign informed consent and be able to cooperate with follow-up\n\nExclusion Criteria:\n\n* Fetal echocardiographic images are incomplete or of poor quality that cannot be used for research;\n* Refusal or loss of follow-up",true,"FEMALE",{"count":637,"type":21},10000,"1 Year","This study addresses congenital heart disease in fetuses, a specific birth defect, by collaborating with multicenter medical institutions across China. It prospectively collects echocardiographic screening, diagnostic images, and structured parameter data from both normal and abnormal fetuses. Cases are followed up, and artificial intelligence (AI) models are developed to extract fetal heart echocardiographic image features and analyze the data. This process allows for the analysis of the AI models' accuracy, sensitivity, and specificity, and verifies the application value of AI models in fetal heart echocardiographic screening and diagnosis.",[26,641],"Artificial Intelligence (AI)","2025-01-26",{"date":644,"type":35},"2025-01-28",{"date":646,"type":21},"2025-02-01",{"date":648,"type":21},"2026-08-01",{"name":632,"class":42}]