[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"truncus-arteriosus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:truncus-arteriosus":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,78,117],{"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":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":5},"100501442","effects-branch-pa-stenting-d-tga-tof-and-ta-100501442","NCT05809310","Effects Branch PA Stenting d-TGA, ToF and TA","The Effects of Branch Pulmonary Artery Stenting in d-TGA, ToF and TA: a Randomized Control Trial","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Patients with d-TGA post ASO, ToF or TA\n* ≥8 years\n\nExclusion Criteria:\n\nOne or more of the following inclusion criteria:\n\n* All class IIa indications for a branch PA intervention:\n* Persistent decreased RV function (based on gold standard CMR)\n\n  * \\\u003C18 years RVEF ≤55% (28)\n  * ≥18 years RVEF\\\u003C50% (29)\n* Progressive tricuspid regurgitation (TR) (≥moderate)\n* Isolated bifurcation stenosis:\n\n  * Significant unilateral stenosis (≥50%)\n  * Borderline bilateral PA stenosis (40-70%)\n* Unbalanced perfusion (≤35\u002F65%)\n* RV\u002FLV pressure ratio \\> 2\u002F3 based on echocardiography\n* Reduced lung perfusion or decreased objective exercise capacity (based of gold standard VO2 max during CPET)\n\n  * \\\u003C18 years VO2 peak \\\u003C35 mL∙kg-1∙min-1 (boys) VO2 peak \\\u003C30 mL∙kg-1∙min-1 (girls) (30)\n  * ≥18 years VO2 peak \\\u003C27 mL∙kg-1∙min-1 (men) VO2 peak \\\u003C19 mL∙kg-1∙min-1 (women) (31)","8 Years",{"count":59,"type":21},56,[24],"The goal of this randomized controlled trial is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA.\n\nThe main question\\[s\\] it aims to answer are:\n\nThe primary study objective is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The secondary objectives are 1) to assess the effects of percutaneous interventions for branch PA stenosis on RV function and 2) to define early markers for RV function and adaptation to improve timing of these interventions.\n\nParticipants will undergo the same series of examinations at baseline and approximately 6 months follow-up (within 6 week time-range) as part of standard care: conventional transthoracic echocardiogram (TTE), cardiopulmonary exercise testing (CPET) and conventional Cardiac Magnetic Resonance (CMR) including a low dose dobutamine stress MRI to assess RV functional reserve. The low dose dobutamine stress MRI will be performed in the interventional group from the UMC Utrecht\u002FWKZ and Erasmus MC because the LUMC and AUMC do not have a suitable infrastructure for the low dose dobutamine stress MRI and this cannot be achieved throughout the duration of this study. The baseline CMR in the interventional group will be performed as close as possible prior to the intervention but maximal 4 weeks prior to the intervention. In addition, the intervention group will undergo standard RV pressure measurements during the intervention. Quality of life (QoL) questionnaires will be obtained at baseline and 2 weeks post intervention (intervention group) or a similar time range in the control group, which is based on experts opinion. TTE, CPET and conventional CMR will be performed within 2-4 years follow-up to assess the long-term effects of percutaneous PA interventions.\n\nResearchers will compare the difference in VO2 max (% predicted) between the interventional group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo a percutaneous intervention for a PA stenosis) and the control group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo conservative management)",[63,30,28,64,65,66,27],"Transposition of Great Vessels","Pulmonary Artery Stenosis Supravalvular Congenital","Stent Stenosis","Right Ventricular Dysfunction",[68],"Exercise capacity","2025-03-25",{"date":71,"type":41},"2025-03-30",{"date":73,"type":41},"2023-04-18",{"date":75,"type":21},"2027-12-31",{"name":77,"class":48},"UMC Utrecht",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":101,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"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":88,"type":21},10000,"OBSERVATIONAL","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.",[27,92,93,29,94,95,28,96,97,98,99,100],"Coarctation of Aorta","Aortic Stenosis","Pulmonary Stenosis","Transposition of the Great Arteries","Single Ventricle","Tetralogy of Fallot (TOF)","Interrupted Aortic Arch","Hypoplastic Left Heart Syndrome (HLHS)","Total Anomalous Pulmonary Venous Connection",[102,103,104,105,106],"congenital heart disease","Integrated prenatal and postnatal model","neonate","surgery","Myocardium regeneration","2025-01-05",{"date":109,"type":41},"2025-01-10",{"date":111,"type":41},"2022-01-01",{"date":113,"type":21},"2030-12-31",{"name":115,"class":48},"Beijing Anzhen Hospital",1,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":148},"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":127,"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.",[131,94,28,63,29,132],"Tetrology of Fallot","Ross Procedure",[134,135,136,137],"Right Ventricular Outflow Tract Reconstruction","Pulmonary Valve","MASA Valve","Pulmonary Valve Replacement","2024-11-04",{"date":140,"type":41},"2024-11-06",{"date":142,"type":41},"2023-05-18",{"date":144,"type":21},"2028-04-01",{"name":146,"class":147},"PECA Labs","INDUSTRY",5]