View clinical trials related to Congenital Heart Disease.
Filter by:Background: Congenital heart disease (CHD) is the most frequent inborn defect with an incidence of 1 in 100 newborns per year, i.e. 800 children born in Switzerland per year. 10% to 15% of cases are born with single ventricle (SV), the most complex type of CHF requiring immediate surgical intervention after birth. Infants with SV CHD are treated in three surgical staged procedures over the first three years of life. However, cerebral injuries occur in around 40% of those children and impact neurocognitive abilities. As more than 90% of all infants with CHD survive to adulthood, scientific concern is focussed on patient-individual course brain growth and development within the relative contribution of fetal, perinatal, cardiac and surgical risk factors. Therefore, serial cerebral MRI examinations are needed, starting (1) at the third trimester during fetal life proceeding to (2) pre- and postoperative time points at the stage I surgery after birth and (3) before stage II surgery at 4 months of age. We will compare the cerebral MRI findings with a healthy control population, recruited at the same time points, and correlate brain growth and development with the neurodevelopmental outcome assessed at one year of age. Three Pediatric Heart Centers in Switzerland and Germany will participate. The overall aims are: 1. To analyse the patient-individual cerebral developmental trajectories, brain growth and determine the time course of brain abnormalities in infants with single ventricle CHD by serial cerebral MRI during fetal life, after birth and at an age of 4 months (primary endpoints). 2. To determine the neurodevelopmental outcome at one year of age using the Bayley III and will be correlated with the brain growth and brain development in the third trimester of fetal life and at the age of 4 months (secondary endpoints). 3. To analyse fetal, neonatal, surgery-related and intensive care associated factors determining the patient-individual course for altered cerebral growth and impaired neurodevelopmental outcome at one year of age. Methodology: We will prospectively enroll fetuses and neonates with single ventricle CHD at the three Pediatric Heart Centers in Switzerland (Zurich, Bern) and Germany (Giessen). Advanced MR imaging will assess cerebral volumes, microstructural and hemodynamic changes at repeated time points during the third trimester of fetal life (32. week of gestation), the perioperative neonatal period before and after stage I surgery and before stage II surgery at 4 months of age. Biomechanical analysis of longitudinal changes of brain morphology will be applied to longitudinal fetal and neonatal MRI data. Outcome is determined with the Bayley-III at one year of age. Significance: Using a population-based sample of children with single ventricle CHD, we will be able to determine cerebral growth from the third fetal trimester until the first 4 months after birth, when the brain is most rapidly growing. By performing serial brain imaging, the knowledge of etiological pattern affecting cerebral growth, development and brain injury will increase. Morphometric and biomechanical analysis of brain growth patterns will be performed that may capture fine-grained changes associated with CHD. By correlating these data with the neurodevelopmental outcome at one year of age it will be possible to identify specific risk constellations leading to impaired brain development and categories of brain injuries that confer a higher risk of adverse outcome. The better understanding of the pathophysiological mechanisms will serve as the basis for neuroprotective studies and pharmacological trials aiming to improve outcomes in children with CHD in the future.
The purpose of this study is to determine if NT-BNP levels obtained at time of admission for delivery are predictive of intrapartum or postpartum complications in patients with adult congenital heart disease.
Management of pregnancy and risk stratification in congenital heart disease (CHD) population might be challenging especially due to physiological haemodynamic modifications that inevitably occur during pregnancy. We aim to compare the accuracy of the main published scores including CARPREG II score in prediction of maternal complications during pregnancy in CHD patients.
Severe pulmonary regurgitation is common in patients with Tetralogy of Fallot and results in progressive right ventricular dilatation and dysfunction. Pulmonary valve replacement is frequent in this population, and percutaneous procedures are increasing. Ventricular arrhythmias are a frequent late complication in patients with tetralogy of Fallot. The most common critical isthmus of ventricular tachycardias is between the pulmonary valve and the ventricular septal defect patch. While an electrophysiology study is sometimes performed in expert centers before surgical pulmonary valve replacement to guide a surgical ablation if needed, this approach is not recommended in current guidelines. An electrophysiology study should also be considered before percutaneous pulmonary valve replacement, as a part of the critical isthmus may be covered by the prosthetic pulmonary valve. Moreover, ablation after percutaneous pulmonary valve insertion exposes patients to the risks of traumatic valve or stent injury and infectious endocarditis. At present, reliable predictors to identify high-risk patients in whom an electrophysiology study should be performed before pulmonary valve replacement are lacking. The aim of this study is to assess prospectively the yield of systematic electrophysiology study and programmed ventricular stimulation before surgical and percutaneous pulmonary valve replacement in patients with tetralogy of Fallot.
Arrhythmias represent one of the main late complications in patients with congenital heart disease. Atrial arrhythmias are associated with a significant morbidity and are the first cause of urgent hospitalization, and sudden death from ventricular arrhythmias is a leading cause of death in this population. The exponential increase of the number of patients with congenital heart disease and the improvement of ablative technologies are associated with a significant increase of the number of catheter ablation procedures. Most of available studies are retrospective or include a limited number of patients. The aim of this study is to assess the efficacy of catheter ablation in patients with congenital heart disease through a national prospective registry. Secondary objectives are i) to identify factors associated with catheter ablation efficacy in different cardiac defects, ii) to describe complications associated with catheter ablation in this specific population, and iii) to assess the impact of catheter ablation on quality of life of patients with congenital heart disease.
This study aims to establish normal coronary artery pulse Doppler flow patterns and velocities using transoesophageal echocardiography (TEE) in patients with a variety of congenital heart disease. This will be accomplished by performing pre-operative and intra-operative TEEs on up to 250 patients undergoing surgery for congenital heart disease.
This clinical trial is being done to see if giving surfactant (Curosurf®) will decrease the number of days that infants will need a breathing tube, decrease the days in the critical care unit and decrease the number of days needed in the hospital. The primary hypothesis for this study is that there will be fewer days needed on mechanical ventilation and improved lung compliance and pulmonary gas exchange.
The Fontan procedure has revolutionized the treatment of patients born with a congenital univentricular heart defect. However, over time, it is associated with severe lymphatic complications such as plastic bronchitis, protein-losing enteropathy (PLE) and peripheral edema. The hypothesis is that patients with a univentricular circulation have a changed morphology which may be associated with both the degree of lymphatic complications and their physical capacity. The morphology will be described using T2-weighted non-contrast MRI.
Valved conduits used for the reconstruction of right-ventricular outflow tract are applied in the surgical repair of complex congenital heart disease(CHD) such as pulmonary atresia(PA), truncus arteriosus, severe tetralogy of Fallot(TOF) for their significant roles in reducing pulmonary valve regurgitation and preserving right ventricle function. With a rising cases of complex CHD and patients with pulmonary valve regurgitation in TOF repair, a further demand is underway for valved conduits. Meanwhile, common biological valved conduits applied in foreign countries are not approved in China yet, with high failure and reintervention, reducing the long-term survival. Our team manufactured a novel valved conduit with 0.1mm expanded polytetrafluoroethylene and gore-tex conduit. This ePTFE valved conduit played a satisfying role in anti-regurgitation and failure rate through in vitro fluid test and animal experiments. Besides, our team manufactured templates for the conduit and also simplified the suturing process so that the repeatability of suturing valved had been risen. Until now, over 70 cases have been implanted with this ePTFE valved conduit with positive early and mid-term follow-up results. Despite the progress which have been made, there still remain some problems to solve. First, systematic prospective randomized comparative study will be performed. Second, this is just a single-center study. Third, these patients should have longer follow-up time to evaluate the ePTFE conduit long-term effect. Finally, imaging data are blank for evaluating the function of the conduit and right ventricle. In this prospective comparative research, the new designed ePTFE valved conduit and bovine jugular vein valved conduits are conducted as a randomized controlled trail. Cardiac magnetic resonance imaging is used to precisely evaluate the anti-regurgitation effect of the valved conduit and the right ventricle function. Investigators can further access the application of this newly designed ePTFE valved conduit. Investigators aim to provide a self-manufactured, low failure rate valved conduit.
Problem: With the increased survival rate of children with congenital heart disease, other health problems, in addition to the clinic, have emerged, such as the risks of developmental delay to which these children are exposed. There is a need for low-cost intervention studies that seek to minimize these risks. Objective: To evaluate the effect of an early stimulation program using parents as vectors of intervention, on the neurodevelopment of children with CHD Methodology: Randomized clinical trial, conducted with 44 dyads of parents-babies with CH considered as medium and high risk for developmental delays according to the guidelines of the American Heart Association (2012). The study will consist of two groups G1 (Intervention) and G2 (controls). G1 parents will receive guidance for 6 weeks of stimulation activities and will be instructed to keep an online execution diary, direct with the researcher through videos, and messages via cell phone. G2 parents will receive the standard guidelines currently used in pediatric cardiology clinics. Children from both groups will be assessed at the beginning and end of the 6 weeks by the Bayley Baby and Toddler Development Scales (3rd Edition). A questionnaire on the applicability of the protocol will be administered to the parents of the intervention group Expected results: Better neuropsychomotor performance in children after applying the early stimulation protocol. Perspectives: Create a body of information that can serve as a basis for the formulation of policies for intervention and surveillance of the development of this population.