[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pulmonary-atresia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pulmonary-atresia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,83,118],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100575392","high-intensity-interval-training-in-patients-with-a-right-ventricle-to-pulmonary-artery-conduit-100575392",false,"NCT06771687","High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit","Right HIIT","Inclusion Criteria:\n\n1. Congenital absence of an unobstructed connection between the right ventricle and pulmonary artery, requiring surgical implantation of a right ventricle to pulmonary artery conduit, including patients with:\n\n   1. Truncus arteriosus\n   2. Pulmonary atresia with ventricular septum defect\n   3. Severe tetralogy of Fallot\n   4. Other forms of pulmonary atresia with biventricular correction\n2. Age 12 to 45 years.\n3. Current follow-up in Academic Center for Congenital Heart Disease (ACAHA; Erasmus MC Rotterdam and Radboudumc Nijmegen).\n4. Signed informed consent.\n\nExclusion Criteria:\n\n1. Ventricular arrhythmias and\u002For channelopathy.\n2. Implantable cardioverter defibrillator implantation due to inherited arrhythmia syndromes.\n3. Left ventricular ejection fraction and\u002For right ventricular ejection fraction less than 30 percent.\n4. Elite athletes (i.e. national team, Olympians, professional athletes, exercising equal to or more than 10 h\u002Fweek, according to definition in 2020 European Society of Cardiology Guidelines for Sports Cardiology and Exercise in Patients with Cardiovascular Disease).\n5. Cardiovascular lesions requiring intervention (according to international guidelines).\n6. Cardiovascular intervention (surgery or catheterization) less than 6 months ago.\n7. Cardiovascular medication changes less than 3 months ago.\n8. Hospitalization for treatment of cardiovascular events less than 6 months ago.\n9. Comorbidities or developmental delay impeding exercise training (e.g. neuromuscular disease, symptomatic myocardial ischemia, syndromic diagnoses such as trisomy 21).\n10. Inability to provide informed consent.","ALL","12 Years","45 Years",{"count":20,"type":21},38,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn if a specific type of exercise training (high intensity interval training) can improve exercise capacity in people with a congenital heart defect that required the creation of a new connection between the right ventricle and pulmonary artery. This includes people with a truncus arteriosus, pulmonary atresia with a ventricular septal defect or severe tetralogy of Fallot. This study focuses on people aged 12 to 45 years. The main questions it aims to answer are:\n\n* Can a 12-week home-based high intensity interval exercise training program increase the exercise capacity?\n* Can factors that predict whether or not the exercise training program can increase the exercise capacity in specific people be identified?\n\nResearchers will compare the results from the intervention group to the control group. Participants will be assigned to one of these two groups at inclusion. The control group will also receive the intervention, after the control period.\n\nParticipants will:\n\n* Participate in a 12-week home-based exercise training program (3x30 minutes a week, digitally supervised);\n* Attend 2 or 3 study visits (which partially is standard care) (2 visits for the intervention group, 3 visits for the control group);\n* Each study visit includes: echocardiography, magnetic resonance imaging (MRI) of the heart, cardiopulmonary exercise testing (CPET), blood and feces sampling, and questionnaires on quality of life and physical activity.",[27,28,29,30],"Congenital Heart Disease","Truncus Arteriosus","Pulmonary Atresia","Tetralogy of Fallot",[32,33,29,30,34,35,36],"Heart Defects, Congenital","Truncus Arteriosus, Persistent","Physical Conditioning, Human","High-Intensity Interval Training","Exercise Test","RECRUITING","2026-01-19",{"date":40,"type":41},"2026-01-21","ACTUAL",{"date":43,"type":41},"2025-01-16",{"date":45,"type":21},"2028-10",{"name":47,"class":48},"Erasmus Medical Center","OTHER",2,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100370678","nirs-in-congenital-heart-defects---correlation-with-echocardiography-100370678","NCT04106479","NIRS in Congenital Heart Defects - Correlation With Echocardiography","Do Cerebral and Renal Saturations Measured With Near-infrared Spectroscopy Correlate With Echocardiographic Markers of Perfusion and Cardiac Performance in Congenital Heart Disease?","Inclusion Criteria:\n\nA prospective study will be conducted of all newborns with tetralogy of fallot, trucus arteriosus, D-transposition of great arteries, PS, AS, coarctation of the aorta, DILV, AVC, DORV, HLHS, TA and PAIVS consecutively admitted at our institution (Montreal Children's Hospital) neonatal intensive care unit (NICU) from January 2018 to January 2020. Patients with CHD will be compared to a control population of term infants admitted and monitored in the NICU with antenatal suspicion of coarctation, ruled-out postnatally.\n\nExclusion Criteria:\n\nPatients will be excluded if premature less than 34 weeks of estimated gestational age (GA) at birth or if parents do not consent. Parental consent can be withdrawn at any time during the study.","0 Days","7 Days",{"count":60,"type":21},100,"OBSERVATIONAL","Neonatal patients with congenital heart defects (CHD) have changing physiology in the context of transitional period. Patients with CHD are at risk of low perfusion status or abnormal pulmonary blood flow. Near infrared spectroscopy has been used in neonatal intensive care units (NICU) to measure end-organ perfusion. The investigator plan on monitoring newborns with CHD admitted to the NICU with NIRS and echocardiography during the first week of life and correlate measures of perfusion from Dopplers to cerebral and renal NIRS.",[64,65,66,67,68,69,70,71,29,72,30],"Congenital Heart Defect","Single-ventricle","Coarctation of Aorta","Atrioventricular Canal","Hypoplastic Left Heart","Transposition of Great Vessels","Interrupted Aortic Arch","Tricuspid Atresia","Aortic Atresia","2025-06-12",{"date":75,"type":41},"2025-06-17",{"date":77,"type":41},"2019-10-11",{"date":79,"type":21},"2025-12-01",{"name":81,"class":48},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":94,"conditions":95,"keywords":103,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":82},"100575109","an-integrated-prenatal-and-postnatal-treatment-model-for-the-treatment-of-newborns-with-critical-congenital-heart-disease-100575109","NCT06768008","An Integrated Prenatal and Postnatal Treatment Model for the Treatment of Newborns With Critical Congenital Heart Disease","Clinical Study of an Integrated Prenatal and Postnatal Treatment Model to Improve the Treatment Effect of Newborns With Critical Congenital Heart Disease","Inclusion Criteria:\n\n1. Full-term infants (gestational age 37-40 weeks): age less than 28 days;\n2. Preterm infants (gestational age greater than 32 weeks but less than 37 weeks): corrected gestational age as neonatal period, age less than 28 days;\n3. Birth weight \\> 1.5 kg;\n4. Fetal diagnosis of congenital heart diseases by ultrasound at 22-26 weeks of gestation, suitable for biventricular repair.\n\nExclusion Criteria:\n\n1. Only suitable for palliative surgery or single ventricle repair;\n2. Associated genetic\u002Fchromosomal abnormalities;\n3. Associated with other severe systemic diseases.","1 Day","28 Days",{"count":93,"type":21},10000,"The purpose of this two-way cohort study was to explore whether an integrated prenatal and postnatal treatment model for neonates with critical congenital heart disease (CCHD) could be effective in avoiding preoperative morbidities, creating an ideal timing for surgery, thereby reducing postoperative in-hospital mortality, and improving surgical prognosis compared with the traditional model of care. In addition, in neonates with CCHD associated with the right cardiac system, the investigators aim to further investigate whether early postnatal cardiac surgery has the potential advantage of obtaining a time window for myocardial regeneration and thus improving myocardial remodeling. The aim of this study is to improve the diagnostic and therapeutic capacity of critical congenital heart disease and to promote the integrated prenatal-postnatal treatment model for clinical use. This will ultimately improve the quality of healthcare services for patients with cardiovascular diseases and lay the foundation for exploring guidelines for the treatment of cardiovascular diseases suitable for China's national conditions.\n\nThe project will be jointly implemented by Beijing Anzhen Hospital , Capital Pediatric Research Institute, and 307 PLA General Hospital. Starting from January 1, 2022, the hospitals will continue to collect hospitalized cases of newborns with CCHD. The integrated prenatal and postnatal model is defined as a definitive diagnosis of CCHD in the fetal period (22-26 weeks), documentation of intrauterine transfer in our obstetrics department, subsequent initiation of an intrapartum or postpartum surgical plan after multidisciplinary consultation, and transfer to the pediatric heart center at the first hour of life, where the child is treated with either postpartum immediate or elective surgery, depending on patient status. For neonates who meet the indications for emergency surgery, surgery is performed immediately after birth. For neonates with non-emergency surgical indications, surgery is performed after birth adjustment to optimal status. The traditional model was defined as postpartum transfer via an outside hospital with routine interventions. The investigators then evaluate surgical prognosis and myocardial regenerative capacity to compare the effects of the two treatment models. This project will validate the advantages of an integrated prenatal and postnatal model over traditional models through real-world research and will improve prognosis in neonates with CCHD.",[27,66,96,29,97,98,28,99,100,70,101,102],"Aortic Stenosis","Pulmonary Stenosis","Transposition of the Great Arteries","Single Ventricle","Tetralogy of Fallot (TOF)","Hypoplastic Left Heart Syndrome (HLHS)","Total Anomalous Pulmonary Venous Connection",[104,105,106,107,108],"congenital heart disease","Integrated prenatal and postnatal model","neonate","surgery","Myocardium regeneration","2025-01-05",{"date":111,"type":41},"2025-01-10",{"date":113,"type":41},"2022-01-01",{"date":115,"type":21},"2030-12-31",{"name":117,"class":48},"Beijing Anzhen Hospital",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":149},"100474040","masa-valve-early-feasibility-study-100474040","NCT05452720","MASA Valve Early Feasibility Study","MVEFS","Inclusion Criteria:\n\n1. At least one of the following: Right Ventricular to Pulmonary Artery mean gradient \\> 35mm Hg, moderate or severe Pulmonary regurgitation (≥3+), or clinical indication for replacement of their native or prosthetic pulmonary valve with a prosthesis.\n2. Age \\\u003C 22 years\n3. Patient is geographically stable and willing to return for 1 year follow-up for the trial.\n4. Patient's legal guardian should be willing to provide informed consent (IC) at the hospital location where they are being enrolled.\n5. The patient, and the patient's parent \u002F legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits.\n\nExclusion Criteria:\n\n1. Patient is in need of or has presence of a prosthetic heart valve at any other position\n2. Patient has a need for concomitant surgical procedures (non-cardiac)\n3. Patients with previously implanted pacemaker (including defibrillators) or mechanical valves\n4. Patient has an active bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics)\n5. Patient has an active endocarditis\n6. Leukopenia, according to local laboratory evaluation of white blood cell count\n7. Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria\n8. Thrombocytopenia, defined as Platelet count \\\u003C 150,000\u002Fmm3 Patients can be transfused to meet eligibility criteria\n9. Severe chest wall deformity, which would preclude placement of the PV conduit\n10. Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials\n11. Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs\n12. Patient has chronic inflammatory \u002F autoimmune disease\n13. Need for emergency cardiac or vascular surgery or intervention\n14. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year\n15. Currently participating, or participated within the last 30 days, in an investigational drug or device study\n16. Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months\n17. Patient has medical, social or psychosocial factors that, in the opinion of the Investigator, could have impact on safety or compliance","0 Years","22 Years",{"count":128,"type":21},10,[24],"The MASA Valve Early Feasibility Study (MVEFS) multi-site interventional clinical trial within the United States of America with each center following a common protocol.The objective of the trial is to evaluate the safety and probable benefit of MASA Valve in the indicated subset of patients requiring Right Ventricular Outflow Tract Reconstruction (RVOTR). As an early feasibility study, the purpose is determine the feasibility of success of the device in order to gather early data towards a future pivotal study and\u002For regulatory clearance submission.",[132,97,28,69,29,133],"Tetrology of Fallot","Ross Procedure",[135,136,137,138],"Right Ventricular Outflow Tract Reconstruction","Pulmonary Valve","MASA Valve","Pulmonary Valve Replacement","2024-11-04",{"date":141,"type":41},"2024-11-06",{"date":143,"type":41},"2023-05-18",{"date":145,"type":21},"2028-04-01",{"name":147,"class":148},"PECA Labs","INDUSTRY",5]