[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pulmonary-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pulmonary-stenosis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100579292","investigation-of-tetralogy-of-fallot-in-neonates-100579292",false,"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.","ALL","1 Minute","6 Months",{"count":21,"type":22},160,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29,30,31],"Tetralogy of Fallot (TOF)","Pulmonary Stenosis","Ventricular Septal Defects (VSD)","Double Outlet Right Ventricle",[33,34,35,36],"Neonatal","Infant","RCT","surgery","RECRUITING","2025-09-03",{"date":40,"type":41},"2025-09-10","ACTUAL",{"date":43,"type":41},"2025-03-01",{"date":45,"type":22},"2028-01-31",{"name":47,"class":48},"Beijing Anzhen Hospital","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":74,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":49},"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":60,"type":22},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.",[64,65,66,67,29,68,69,70,28,71,72,73],"Congenital Heart Disease","Coarctation of Aorta","Aortic Stenosis","Pulmonary Atresia","Transposition of the Great Arteries","Truncus Arteriosus","Single Ventricle","Interrupted Aortic Arch","Hypoplastic Left Heart Syndrome (HLHS)","Total Anomalous Pulmonary Venous Connection",[75,76,77,36,78],"congenital heart disease","Integrated prenatal and postnatal model","neonate","Myocardium regeneration","2025-01-05",{"date":81,"type":41},"2025-01-10",{"date":83,"type":41},"2022-01-01",{"date":85,"type":22},"2030-12-31",{"name":47,"class":48},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":104,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":119},"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":97,"type":22},10,[25],"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.",[101,29,69,102,67,103],"Tetrology of Fallot","Transposition of Great Vessels","Ross Procedure",[105,106,107,108],"Right Ventricular Outflow Tract Reconstruction","Pulmonary Valve","MASA Valve","Pulmonary Valve Replacement","2024-11-04",{"date":111,"type":41},"2024-11-06",{"date":113,"type":41},"2023-05-18",{"date":115,"type":22},"2028-04-01",{"name":117,"class":118},"PECA Labs","INDUSTRY",5]