ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Mitral Bioprostheses (Models 11000A and 11000M) With a New Tissue Treatment Platform (COMMENCE)

The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic mitral valve.

Congenital Heart Disease Genetic Network Study

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 i

A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Parenchymous Tissue Open Surgeries

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).

A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination with Sofosbuvir for the Treatment of Post-Liver Transplant Subjects with Chronic Hepatitis C

The primary objective of this program is to provide DCV for 24 weeks to be given in combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or post-liver transplant subjects with chronic hepatitis C recurrence with either advanced fibrosis or fibrosing cholestatic hepatitis and who have a serious or immediately life-threatening condition or experienced an event that has decreased their life expectancy to <12 months, therefore, no research hypothesis will be tested and no specific endpoints are defined.

De Novo Autoimmune Hepatitis in Pediatric Liver Transplantation

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.

Trial Website: https://clinicaltrials.gov/show/NCT02056054

A 24-month, multi-center, single arm, prospective study to evaluate renal function, efficacy, safety and tolerability of everolimus in combination with reduced exposure cyclosporine or tacrolimus in paediatric liver transplant : CRAD001H2305

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.

Trial Website: https://clinicaltrials.gov/show/NCT01598987

A Multi-Center, Randomized, Prospective, Open-Label Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Hepatitis C Immune Globulin Intravenous (Human), Civacir, in Orthotopic Liver Transplant Recipients

The purpose of this study is to test the safety and efficacy of Civacir® to prevent the recurrence of Hepatitis C Virus (HCV) after liver transplant.

Trial Website: https://clinicaltrials.gov/show/NCT01804829