This is a multi-center prospective, single-arm, non-randomized, open label study to assess feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring Right Ventricular Outflow Tract correction or reconstruction due to congenital heart malformations.
Congenital heart disease (CHD) is the most common birth defect with an incidence of 1 in 100 live births. Many cytogenetic abnormalities have been associated with CHD. Evidence is accumulating that many developmental defects can result from small genomic alterations invisible at the cytogenetic level, resulting in changes in copy number of contiguous genes. As a site in the National Heart, Lung, and Blood Institute-sponsored Pediatric Cardiac Genomics Consortium (PCGC) we will work to help elucidate the potential genetic causes of congenital heart disease. Our goal is to recruit 2000 fa
This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the liver). The purpose of this study is to demonstrate that FS Grifols is not inferior to commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage of bleeding).
The purpose of this study is to provide insights into the cause, development and effects of de novo autoimmune hepatitis so that prevention and treatment strategies can be developed in order to reduce post-liver transplant morbidity, the frequency of liver allograft loss and the need for re-transplantation.
This study is designed to assess the evolution of renal function and to collect efficacy, safety, and tolerability data of everolimus in co-exposure with reduced CNI in paediatric liver transplant recipients.
Anti-rejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent rejection of the new organ. Long-term use of these medicines places transplant recipients at higher risk of serious infections and certain types of cancer.
To enter scientific and personal data on patients undergoing pediatric liver transplantation into a national registry.
Long term follow up for CTOTC-04 patients and 2 year observational study looking at allo-antibodies in newly transplanted patients both sensitized and non sensitized.
The purpose of this pilot trial, Transitioning to Adult Care (TRANSIT), is to develop and test an intervention (i.e., a standardized, tailored transition program focused on enhancing adherence) to improve outcomes for emerging adults who underwent heart transplantation as children and transfer to adult care.
To determine the ability of established and novel cardiac biomarkers to predict short- and long-term outcomes.