View clinical trials related to Congenital Heart Disease.
Filter by:The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.
Patients under deep sedation and general anesthesia lose heat to their surrounding environment. Hypothermia after anesthesia is associated with worse patient outcomes, including increased number of infections and cardiovascular complications. Cardiac MRI scans performed for patients who require general anesthesia can cause a loss of body heat. Several mechanisms exist for reducing hypothermia under anesthesia including forced air warmers, fluid warmers, radiant warmers, and chemical warmers. Unfortunately, there are no MRI-compatible systems which allow patient warming and prevention of hypothermia in anesthetized patient in the MRI-scanner. This study is testing a non-invasive device that warms patients under clinically indicated general anesthesia in the MRI scanner. This device will keep in the heat made by the MRI scanner.
General objective of the research project: To evaluate the alterations of systemic microvascular reactivity during cardiopulmonary bypass (CPB), in children submitted to cardiac surgery for repair of congenital heart defects.
The goal of the Fontan Imaging Biomarkers (FIB) study is to identify the associations of blood and urine biomarkers to imaging parameters of ventricular mechanics.
To examine retrospectively whether transcatheter closure of the interatrial septum leads to myocardial injury and to determine the mechanism.
This is an investigator initiated, prospective, single-center, double-blinded, randomized, placebo-controlled trial of post-operative low dose vasopressin infusions as an early treatment of low systemic perfusion in pediatric patients following Fontan palliation.
Cardioplegic arrest is an essential part of cardiac surgery which aims to allow myocardial preservation and minimise myocardial swelling ,while providing a motionless and bloodless field ,.Blood cardioplegia has proven its efficacy for several decades and surgeons are still preferring to use it for myocardial protection of paediatric cardiac surgery ,although it is thought to be more time consuming since it is given with interrupted doses, . Even when advancement has came along the field of myocardial protection and cardioplegia solutions with the introduction of Bretschneider Histidine-Tryptophan-Ketoglutarate solution ,custodiol ,in 1970 ,which is given as a single dose and believed to be convenient, simple to deliver , and less time consuming . Many Surgeons haven't change their practice possibly due to paucity of studies comparing cardioplegia solutions in paediatric cardiac surgery and conflicting reports regarding the superiority of different cardioplegia solution.The investigators aim to provide evidence that will help paediatric cardiac surgeons to choose the optimal solution for their practice .
Adults with a congenital heart disease, having undergone a surgical intervention or a re-do surgery in adulthood, are a growing group of subjects in the general population. This increase is explained by improved medical and surgical techniques, with a better survival rate as outcome. There is nowadays a growing interest in the quality of life of this group of subjects. However, studies give contradictory results. This can be explained on one hand by the vast majority of pathologies within this population, and on the other hand by the absence of a cardio-specific tool for quality of life measurement. The MacNew questionnaire is cardio-specific. It allows an evaluation of the quality of life based on the exploration of three domains: physical, emotional and social. The aim of this study is: - to evaluate the quality of life of these patients, by using the MacNew questionnaire - to explore the needs in terms of prevention, treatment and multi-disciplinary follow-up - to assess the mortality within this group of patients.
Congenital heart diseases are nowadays frequently treated in newborns. These congenital heart defects can directly affect the right ventricular ejection tract (RVOT), or sometimes indirectly, when the left ventricular ejection tract (LVOT) is replaced by the ROVT in a Ross operation. Originally introduced by Ross and Somerville in 1966, the reconstruction of ROVT by valved homografts is since then widely used.Pulmonary and aortic homografts then constituted the gold standard in conduit replacement between the right ventricle and the pulmonary artery (VD-AP). The increasing demand for homografts currently induces a shortage and unmet demands. This lack of availability, and the durability of homografts in young patients, has encouraged the search for alternative conducts.For example, in 1999, Medtronic® put a bovine jugular vein xenograft (VJB) on the market, the Contegra® conduct, as alternative for the homograft for RVOT reconstruction. This duct naturally has a central valve with three valvules, and there is on both sides of the valve a generous duct length allowing unique adaptation options. This conduit, however, is not perfect. Whether using Contegra® ducts or homografts, replacement is inevitable. The aim of this study is to compare operative morbidity and mortality when replacing Contegra® or homograft.
One of the most common hemostatic derangements in pediatric open- heart surgery is an acute acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet aggregation, resulting in increased bleeding and allogenic blood transfusions. Currently, fresh frozen plasma and cryoprecipitate are used to supplement fibrinogen in pediatric cardiac patients. We propose that replacing cryoprecipitate with fibrinogen concentrate will be as effective in treating post-CPB bleeding and will decrease total blood product exposure when used as part of a blood transfusion algorithm. We plan to include all patients undergoing cardiac surgery on CPB less than 12 months and a fibrinogen level <250mg/dL while on bypass. We hope to demonstrate that fibrinogen concentrate is at least as effective as the standard of care in the management of peri- operative bleeding in neonatal patients undergoing cardiopulmonary bypass. If we are able to demonstrate that fibrinogen is at least as effective as the standard of care, then we would plan a multi-center trial to demonstrate the safety and efficacy of this medication. If we are able to demonstrate that fibrinogen concentrate is effective, fibrinogen concentrate could replace allogenic products and potentially decrease transfusion related morbidity in mortality in this population.