[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"complex-congenital-heart-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:complex-congenital-heart-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,69,90,122,148],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100636957","preliminary-efficacy-of-a-remote-cardiac-rehabilitation-program-in-pediatric-patients-with-complex-congenital-heart-disease-100636957",false,"NCT07572435","Preliminary Efficacy of a Remote Cardiac Rehabilitation Program in Pediatric Patients With Complex Congenital Heart Disease","Preliminary Efficacy of a Community-Based Remote Cardiac Rehabilitation Program on Cardiopulmonary Function and Quality of Life in Pediatric Patients With Complex Congenital Heart Disease: A Single Blind, Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 8 to 18 years.\n* Diagnosed with complex congenital heart disease (e.g., single ventricle, transposition of the great arteries) and have a history of cardiac surgery.\n* At least 3 months post-cardiac surgery and maintaining a stable hemodynamic status.\n* Capable of utilizing remote programs (mobile apps, video platforms, etc.) in the home environment with technical support from guardians.\n* Participant or guardian has agreed to participate and signed the written informed consent form.\n* Confirmed to have decreased physical activity level and physical well-being through assessments (Must meet both):\n* KIDSCREEN-27 Parent Proxy-report 'Physical well-being' domain T-score of 40 or below.\n* Exercise Vital Sign (EVS) survey indicating moderate-to-vigorous physical activity (MVPA) time of less than 420 minutes per week.\n\nExclusion Criteria:\n\n* Ongoing cardiovascular diseases such as uncontrolled arrhythmia, acute heart failure, myocarditis, or pericarditis.\n* Neurological or musculoskeletal disorders that make independent exercise impossible.\n* Cognitive impairment that prevents understanding or following the instructions of the remote rehabilitation program.\n* Clinical levels of depression or anxiety restricting exercise participation, as determined by the attending physician (assessed via Korean Children's Depression Inventory 2: Self-Report \\[K-CDI-2:SR\\] and Revised Children's Manifest Anxiety Scale, Second Edition \\[RCMAS-2\\]).\n* Inability to cooperate with study tests, such as the Cardiopulmonary Exercise Test (CPET), Electrocardiogram (ECG), and 6-Minute Walk Test (6MWT).\n* Currently wearing an artificial pacemaker.","ALL","8 Years","18 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to evaluate the preliminary efficacy of a 12-week community-based remote cardiac rehabilitation program on cardiopulmonary function and quality of life in pediatric patients (aged 8 to 18 years) with complex congenital heart disease. Participants will be randomly assigned to either an experimental group receiving the remote cardiac rehabilitation program or a control group receiving the standard of care.",[27],"Complex Congenital Heart Disease","RECRUITING","2026-05-06",{"date":31,"type":32},"2026-05-07","ACTUAL",{"date":34,"type":21},"2026-05-01",{"date":36,"type":21},"2029-12-31",{"name":38,"class":39},"Seoul National University Hospital","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":48,"targetDuration":50,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":40},"100633308","a-chinese-multicenter-study-on-surgical-techniques-and-outcomes-across-the-lifespan-in-congenital-heart-disease-100633308","NCT07524998","A Chinese Multicenter Study on Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease","Evaluation of Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease Based on a Chinese Multicenter Database","Inclusion Criteria:\n\n* Clinical diagnosis of Complex Congenital Heart Disease (CCHD) who underwent surgical intervention and were enrolled in the 13th Five-Year Plan National Congenital Heart Disease Surgery Database\n* Clinical diagnosis of CCHD requiring surgical\u002Fintrauterine intervention or cardiac rehabilitation\n* Willing to sign informed consent and complete follow-up\n\nExclusion Criteria:\n\n* Lost to follow-up\n* \\>30% missing core clinical data\n* Severe extracardiac malformations, systemic dysfunction, or other conditions precluding study participation, per sub-study specific exclusion criteria",{"count":49,"type":21},3000,"1 Year","OBSERVATIONAL","The goal of this observational study is to learn about recovery after heart surgery for people with Complex Congenital Heart Disease (CCHD), build a comprehensive data platform for CCHD care across a person's whole life, and create a China-specific quality control system to improve CCHD surgical care.\n\nThe main questions it aims to answer are:\n\nWhat are the main risk factors that affect how well people with CCHD recover after heart surgery? Can a whole life course, multi-dimensional data platform for CCHD care be built to support better clinical quality control? Can a China-specific system to evaluate and control the quality of CCHD heart surgery be developed to guide national health policies and improve patient outcomes?\n\nParticipants in this study are people with CCHD who have had or will have heart surgery at participating medical centers. This includes two groups:\n\nA retrospective group: People who already had CCHD heart surgery and were included in the existing National Congenital Heart Disease Surgery Database.\n\nA prospective group: People who are scheduled to have CCHD heart surgery as part of related sub-studies of this project.\n\nPeople who are lost to follow-up or have more than 30% missing data will not be included.\n\nParticipants will:\n\nFor the retrospective group: Have their past medical records (from surgery and follow-up) analyzed by researchers to find risk factors linked to recovery after CCHD heart surgery.\n\nFor the prospective group: Have their pre-surgery tests, surgery details, care during and after surgery, and follow-up data (including up to 1 year after surgery) collected as part of their regular medical care.\n\nResearchers will combine data from both groups into a new registry, work with a third-party committee to check data quality, and use this combined data to build a quality control and evaluation system for CCHD heart surgery. This system will help show the current state of CCHD care in China and guide national health decisions.",[54,27,55,56,57,58],"Congenital Heart Disease","Surgery (Cardiac)","Perioperative Care","Quality Control","Health Care","2026-04-10",{"date":61,"type":32},"2026-04-13",{"date":63,"type":32},"2025-02-01",{"date":65,"type":21},"2029-01-31",{"name":67,"class":68},"China National Center for Cardiovascular Diseases","OTHER_GOV",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":87,"locationsCount":89},"100620893","multicenter-randomized-controlled-trial-rct-and-efficacy-evaluation-system-study-on-surgical-innovation-strategies-for-neonatal-complex-congenital-heart-disease-100620893","NCT07363538","Multicenter Randomized Controlled Trial (RCT) and Efficacy Evaluation System Study on Surgical Innovation Strategies for Neonatal Complex Congenital Heart Disease","Inclusion Criteria:\n\n1. Neonates diagnosed with TAPVC, CoA\u002FIAA, TGA, PA\u002FIVS, or severe PS via pre-admission cardiac echocardiography;\n2. Patients and families demonstrating high compliance, willing to sign informed consent forms and agree to complete one year of follow-up and related examinations.\n\nExclusion Criteria:\n\n1. Preterm infant (gestational age \\\u003C 36 weeks at birth);\n2. Low birth weight (weight \\\u003C 2.5 kg);\n3. Concurrent severe extracardiac anomalies or complex cardiac malformations;\n4. Preoperative respiratory or circulatory instability requiring emergency surgery.","7 Days",{"count":77,"type":21},738,[24],"There remains controversy regarding the optimal timing of surgical treatment for neonatal CCHD (Complex Congenital Heart Disease). Based on the established national multi-center database for surgical treatment of congenital heart disease and the prenatal-postnatal integrated diagnosis and treatment model, this study will conduct a multi-center RCT (Randomized Controlled Trial) to explore the optimal surgical timing for neonatal CCHD. It will also develop innovative comprehensive treatment strategies for critically ill neonatal CCHD patients, use RCT data to evaluate treatment efficacy and establish an evaluation system. This system will be gradually promoted nationwide, aiming to reduce the incidence of perioperative mortality and non-recovery discharge in CCHD patients by 50% (National in-hospital mortality rate of neonatal congenital heart disease surgery in 2023: 6.5%; non-recovery discharge rate: 12.66%), thereby improving the overall level of CCHD treatment in China.",[27],"2026-01-15",{"date":83,"type":32},"2026-01-23",{"date":85,"type":32},"2025-12-01",{"date":65,"type":21},{"name":88,"class":39},"Central China Fuwai Hospital of Zhengzhou University",12,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100498217","phase-2-fetal-cerebrovascular-autoregulation-in-congenital-heart-disease-and-association-with-neonatal-neurobehavior-100498217","NCT05767385","Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior","Inclusion Criteria:\n\n* Pregnant women 18 years of age and over with a singleton fetus with known or suspected congenital heart disease anticipated to need intervention or surgery within 30 days of birth.\n\nExclusion Criteria:\n\n* Known fetal chromosomal or genetic abnormalities\n* Multiple gestation pregnancy\n* Fetal extra-cardiac anomalies","FEMALE","0 Years","52 Years",{"count":100,"type":21},150,[102,103],"PHASE2","PHASE3","Determine 1) the impact of abnormal fetal cerebrovascular physiology with neurodevelopmental delay (ND) outcomes and 2) how this relationship is modified by patient and environmental factors such as chronic congenital heart disease (CCHD) lesion, maternal-fetal environment, and social determinants of heath (SDOH) in a diverse population using a multicenter design.\n\nPregnant women will be approached during one of their fetal cardiology clinic visits.",[106,107,108,27],"Congenital Heart Disease in Children","Hypoxia","Neurodevelopmental Disorders",[54,110,111],"Maternal Fetal","Neonatal Neurodevelopment","2025-06-18",{"date":114,"type":32},"2025-06-25",{"date":116,"type":32},"2021-12-17",{"date":118,"type":21},"2025-12",{"name":120,"class":39},"University of Utah",5,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":147,"locationsCount":40},"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":130,"type":21},10,[24],"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.",[134,27,106],"Congenital Heart Disease (CHD)",[136,137,138,139],"Complex congenital heart disease","remote cardiac rehabilitation","cardiac rehabilitation","children cardiac rehabilitation","NOT_YET_RECRUITING","2025-03-30",{"date":143,"type":32},"2025-04-04",{"date":145,"type":21},"2025-05-31",{"date":36,"type":21},{"name":38,"class":39},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":156,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":163,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":40},"100584031","support-for-the-management-of-parental-stress-in-surgical-resuscitation-of-congenital-heart-diseases-100584031","NCT06884046","Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases","Evaluation of the Feasibility of Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases","Et APRéS Ca","Inclusion Criteria:\n\n* Parents whose fetus has congenital heart disease diagnosed in antenatal, which will be operated in the neonatal period (between 0 and 28 days of life) within our sector.\n* Parents followed in the congenital heart disease sector of the University Hospital of Bordeaux as soon as the diagnosis is announced in antenatal.\n* Free, informed and signed written consent of the couple or single mother in a single parent setting or by a third person (in case of physical disability of the participant) and the investigator (no later than the day of inclusion and before any examination required by the research).\n* Person affiliated or beneficiary of a social security scheme (excluding AME).\n* Parents with parental authority.\n\nExclusion Criteria:\n\n* Parents who do not understand or read French and cannot be accompanied by a third party for translation.\n* Parents with major psychiatric disorders.\n* Parents deprived of liberty due to ongoing legal proceedings.\n* Parents under guardianship or curatorship or unable to personally express consent.","0 Days","28 Days",{"count":159,"type":21},40,[24],"Half of children with congenital heart disease develop specific neurodevelopmental disorders. Neurodevelopmental disorders are the leading cause of morbidity in these children. They can be increased by perioperative complications, the family and economic socio-economic environment and the level of parental stress. The stress perceived by parents of children with congenital heart disease varies depending on the time of diagnosis, the organization of care inherent in neonatal management and the type of pathology diagnosed.\n\nThe main objective is to evaluate the feasibility of a multidisciplinary and personalised model of support for parental stress, from the ante-natal period, in the context of their child's neonatal cardiac surgery.",[27],[164,165,166],"Neurodevelopment","Stress parental","Parental guidance","2025-03-12",{"date":169,"type":32},"2025-03-19",{"date":171,"type":32},"2025-02-06",{"date":173,"type":21},"2027-02-06",{"name":175,"class":39},"University Hospital, Bordeaux"]