[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tetralogy-of-fallot-tof\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tetralogy-of-fallot-tof":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,89,119,152],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100637846","validation-of-ecg-based-ventricular-arrhythmia-localization-algorithms-in-patients-with-repaired-tetralogy-of-fallot-100637846",false,"NCT07607821","Validation of ECG-Based Ventricular Arrhythmia Localization Algorithms in Patients With Repaired Tetralogy of Fallot","Validation of ECG-Based Ventricular Arrhythmia Localization Algorithms in Patients With Repaired Tetralogy of Fallot: A Prospective Pace Mapping Study","Inclusion Criteria:\n\n* Adult patients \\>\u002F= 18 years with repaired tetralogy of Fallot with pulmonary stenosis scheduled for clinically-indicated diagnostic electrophysiology (EP) study.\n\nExclusion Criteria:\n\n* Dextrocardia or mesocardia.\n* Double outlet right ventricle.\n* Tetralogy of Fallot with pulmonary atresia.\n* Contraindication to femoral arterial access.\n* Mechanical aortic prosthesis.\n* Inability to provide informed consent.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"NA","Doctors use patterns on heart rhythm tracings (ECGs) to predict where abnormal heart rhythms originate, but these prediction methods were developed in people with normal heart structure. Patients with repaired Tetralogy of Fallot have hearts that developed differently, and cardiologists do not know if these prediction methods work accurately for them. In this study, the investigators will test whether three commonly used prediction methods work in Tetralogy of Fallot patients by pacing the heart from known locations during an already-scheduled heart procedure and comparing the predicted location to the actual location. Participation adds approximately 15 minutes to the procedure and does not require additional visits. The results will help cardiologists understand whether current methods can be trusted when planning treatments for abnormal heart rhythms in this patient population, or whether new prediction methods need to be developed.",[26,27],"Tetralogy of Fallot (TOF)","Ventricular Tachycardia","NOT_YET_RECRUITING","2026-06-04",{"date":31,"type":32},"2026-06-05","ACTUAL",{"date":34,"type":20},"2026-07",{"date":36,"type":20},"2027-07",{"name":38,"class":39},"Boston Children's Hospital","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":50,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":61,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100587722","adult-congenital-heart-disease-international-evaluation-of-the-effectiveness-of-sglt2i-registry-100587722","NCT06932081","Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry","Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i (ACHIEVE-SGLT2i) Registry","ACHIEVE-SGLT2i","Inclusion Criteria:\n\n* Congenital heart defect.\n* Age ≥ 18 years.\n* Initiated on treatment with an SGLT2i.\n\nExclusion Criteria:\n\n\\- No consent for data collection.",{"count":49,"type":20},400,"1 Year","OBSERVATIONAL","This real-world, international registry aims to evaluate the current experience with sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adult congenital heart disease (ACHD) patients by investigating the prescription patterns, safety, tolerability, and potential beneficial effects on heart failure-related outcomes.",[54,55,56,57,58,59,60,26],"Adult Congenital Heart Disease","Congenital Heart Disease","Systemic Right Ventricle","Transposition of the Great Arteries","Congenitally Corrected Transposition of the Great Arteries","Fontan","Single Ventricle",[62,63,64,65,66,67,68,69,70,71,72,73,74,59,75,76,77],"adult congenital heart disease","ACHD","congenital heart disease","CHD","sodium-glucose cotransporter 2 inhibitors","SGLT2i","SGLT2","heart failure","HF","transposition of the great arteries","TGA","systemic right ventricle","sRV","single ventricle","tetralogy of fallot","ToF","RECRUITING","2026-02-11",{"date":81,"type":32},"2026-02-13",{"date":83,"type":32},"2023-01-01",{"date":85,"type":20},"2027-12-31",{"name":87,"class":39},"Leiden University Medical Center",11,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":4},"100618023","effect-of-exercises-on-ventilatory-function-in-adult-with-tof-100618023","NCT07326228","Effect of Exercises on Ventilatory Function in Adult With TOF","Effect of Combined Inspiratory Muscle Training and Aerobic Exercises on Ventilatory Function in Adults With Repaired Tetralogy of Fallot","Inclusion Criteria:\n\n* Diagnosed with TOF.\n* Have surgical correction of the abnormality.\n* Class II-III according to New York Heart Association (NYHA)\n* Ejection fracture \\> 40\n* Vitally stable during the study period\n\nExclusion Criteria:\n\n* Resent cardiopulmonary surgery or intervention \"less than 6 months\"\n* Presence of pulmonary disease which is not a complication of TOF (eg:\n\nbronchial asthma, lung fibrosis…..)\n\n* Neuromuscular or musculoskeletal disease and severe scoliosis affecting pulmonary function or physical exercise.\n* Mental or physical limitations\n* active infection or systemic illness.\n* Hemodynamic instability\n* Mouth burn, injury, or deformities\n* Implanted pacemaker","30 Years",{"count":98,"type":20},60,[23],"The goal of this clinical trial is to learn if combined inspiratory muscle training and aerobic exercise can improve ventilatory function in adults with repaired Tetralogy of Fallot (TOF). It will also learn if exercises work to raise functional capacity and Quality of life (QoL) . The main questions it aims to answer is:\n\n* Dose combined inspiratory muscle training and aerobic exercise (study group) improve ventilatory function in adults with repaired (TOF) more than aerobic exercise only (control group)?\n* Can combine inspiratory muscle training and aerobic exercise (study group) raise functional capacity and (QoL) in adults with repaired (TOF) more than aerobic exercise only (control group)?\n\nResearchers will compare between combination of inspiratory muscle training and aerobic exercise on one group and the aerobic exercise only on other group, on ventilatory function, functional capacity and (QoL) on adults with repaired TOF.\n\nParticipants will:\n\nOn study group , participants will perform respiratory muscle training in addition to moderate intensity aerobic exercise for 6 weeks. 3 times\u002Fweek\n\nOn controlled group , participants will perform moderate intensity aerobic exercise for 6 weeks. 3 times\u002Fweek.\n\nall participants will test ventilatory function , functional capacity and will answer a survey questions about their quality of life before and after training",[26,102],"Adults With Repaired Tetralogy of Fallot",[64,104,105,106,107,108,109],"tetralogy of Fallot","inspiratory muscle training","aerobic exercise","ventilatory functions","functional capacity","Quality of life","2025-12-24",{"date":112,"type":32},"2026-01-08",{"date":114,"type":20},"2026-01-01",{"date":116,"type":20},"2027-01-31",{"name":118,"class":39},"Cairo University",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":131,"briefSummary":132,"conditions":133,"keywords":137,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100579292","investigation-of-tetralogy-of-fallot-in-neonates-100579292","NCT06822400","Investigation of Tetralogy of Fallot in Neonates","A Multi-center, Randomized, Controlled Investigation of Tetralogy of Fallot in Neonates","RIFAN","Inclusion Criteria:\n\nClinical diagnosis of TOF's Disease. Full-term neonates aged ≤28 days. Birth weight of all eligible male or female patients \\>2.5 kg. All included study participants must be able to give an informed consent\n\nExclusion Criteria:\n\nPreterm infants . Coexisting complex cardiac anomalies. Severe TOF with pulmonary artery hypoplasia , recurrent hypoxic episodes , or conditions warranting palliative or single-ventricle repair.\n\nExtra-cardiac anomalies, including genetic or chromosomal abnormalities. Neonatal bronchopulmonary dysplasia. Deteriorating conditions in the control group precluding surgery by 3 months of age.\n\nParental refusal to participate in the clinical trial.","1 Minute","6 Months",{"count":130,"type":20},160,[23],"Child health serves as the foundation for overall public health, with neonatal mortality recognized globally as a comprehensive indicator of national health standards and societal advancement. The Healthy Children Action Improvement Plan (2021-2025) sets a national target to reduce neonatal mortality in China to below 3.1‰. Congenital heart disease (CHD), the most prevalent congenital defect among neonates, constitutes a significant cause of disability and premature death in the Chinese population. Annually, approximately 70,000-80,000 neonates are born with CHD, among whom nearly 10,000 present with critical congenital heart disease (CCHD). Postnatal manifestations of CCHD often include cyanosis, hypoperfusion, and respiratory distress, with untreated cases resulting in approximately 50% mortality. CCHD is one of the leading causes of infant death.\n\nTetralogy of Fallot (TOF), the most common form of CCHD, accounts for a substantial proportion of cyanotic congenital heart diseases. It is characterized by four anatomical abnormalities: ventricular septal defect, pulmonary stenosis, overriding aorta, and right ventricular hypertrophy. These structural defects disrupt intracardiac blood flow, reduce arterial oxygen saturation, and result in cyanosis and other related symptoms. Untreated TOF leads to significant health issues early in life, including growth retardation, recurrent hypoxic episodes, heart failure, and increased susceptibility to infections. Long-term survival is markedly reduced, with only a small proportion surviving into adulthood. Thus, surgical intervention is pivotal for improving outcomes in TOF(Tetralogy of Fallot) patients.\n\nDespite advances in medical technology yielding satisfactory early outcomes, long-term prognosis following TOF correction remains a challenge. Historically, surgical strategies emphasized complete relief of right ventricular outflow tract obstruction, often at the expense of pulmonary valve function. Recent studies, however, highlight the critical role of preserving pulmonary valve function in improving long-term outcomes, as pulmonary valve dysfunction is a leading cause of late right ventricular failure and reintervention. Additionally, surgical approaches, whether via atrial or ventricular access, have inherent advantages and limitations, but neither can fully eliminate the risk of postoperative arrhythmias associated with TOF's anatomical complexity and surgical impact. These issues underscore the necessity for further advancements in long-term management strategies.\n\nSurgical correction of TOF in a single-stage procedure has become standard practice, with the timing of surgery progressively shifting to earlier ages-from school age in the 1990s to the current standard of 3-6 months of age. This timing ensures sufficient weight and organ maturity to withstand the complexities of cardiac surgery. However, in clinical practice, significant challenges persist, including: (1) Deterioration during the waiting period, during which patients may experience recurrent hypoxic episodes, inadequate weight gain, and exacerbated pulmonary vascular underdevelopment, thereby complicating definitive surgery and increasing perioperative risk. (2) Developmental delays due to chronic hypoxemia and heart failure, potentially leading to neurological deficits and pulmonary hypertension, adversely affecting cognitive and motor development. Neonatal repair, performed within 28 days of life, may mitigate these challenges by restoring normal circulatory physiology at the earliest possible stage.\n\nInternational guidelines endorse neonatal TOF repair for capable centers, citing the potential for enhanced clinical benefits and superior prognoses. Clinical observations at our center indicate several advantages of neonatal TOF repair, including reduced intraoperative bleeding, cleaner surgical fields, and better pulmonary vascular development. These benefits may be attributed to the regenerative potential of neonatal myocardial cells and the absence of prolonged pathological circulatory states, which otherwise exacerbate anatomical abnormalities. Early intervention may reduce right ventricular fibrosis and pulmonary vascular pathology, thereby improving long-term outcomes.\n\nWith advancements in surgical techniques and perioperative care, neonatal TOF repair has become a routine practice at our center, with over 100 cases performed annually for two consecutive years. This success is supported by an integrated prenatal-to-postnatal care model, establishing a comprehensive treatment framework.\n\nGiven this context, the investigators propose a multicenter, randomized controlled trial (RCT) to compare the safety and efficacy of neonatal and infant TOF repair. This study aims to provide high-quality evidence for clinical practice, determine optimal surgical timing, and enhance overall survival rates and quality of life for TOF patients.",[26,134,135,136],"Pulmonary Stenosis","Ventricular Septal Defects (VSD)","Double Outlet Right Ventricle",[138,139,140,141],"Neonatal","Infant","RCT","surgery","2025-09-03",{"date":144,"type":32},"2025-09-10",{"date":146,"type":32},"2025-03-01",{"date":148,"type":20},"2028-01-31",{"name":150,"class":39},"Beijing Anzhen Hospital",1,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":159,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":163,"conditions":164,"keywords":172,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":151},"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":162,"type":20},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.",[55,165,166,167,134,57,168,60,26,169,170,171],"Coarctation of Aorta","Aortic Stenosis","Pulmonary Atresia","Truncus Arteriosus","Interrupted Aortic Arch","Hypoplastic Left Heart Syndrome (HLHS)","Total Anomalous Pulmonary Venous Connection",[64,173,174,141,175],"Integrated prenatal and postnatal model","neonate","Myocardium regeneration","2025-01-05",{"date":178,"type":32},"2025-01-10",{"date":180,"type":32},"2022-01-01",{"date":182,"type":20},"2030-12-31",{"name":150,"class":39}]