Extrait

Background and study aims Congenital heart disease (CHD) is the general term used to describe a range of birth defects that affect the heart. The majority of children born with a congenital heart defect (CHD) now live into adulthood. Many of them need repeated operations throughout life to replace the valves on the right side of the heart (pulmonary valves). The standard operation for valve replacement involves opening the chest so that the heart is accessible to the surgeon and the use of the heart lung machine to take over the function of the heart and lungs (pumping blood and oxygen through the body) during the operation. It has been found however, that repeated use of the heart lung machine is associated with complications, such as excessive bleeding, heart damage, stroke, and even death, and so it is preferable to avoid using them if possible. In recent years, new types of “injectable” self-expanding artificial valves have been developed for pulmonary valve replacement (PVR) procedures. They have been developed so they can be “injected” into position with the heart still beating (avoiding the need to use the heart lung machine) and without a need for the surgeon to fully expose the heart. The aim of this study is to find out if using injectable valves leads to a quicker recovery and shorter stay in hospital, saving money for the NHS, and whether they work as well as standard valves. Who can participate? Patients aged between 12 and 80 who are having a PVR procedure. What does the study involve? Participants are randomly allocated to one of two groups. Participants in the first group have the conventional PVR procedure, involving opening the chest to replace the affected valve, while using the heart lung machine to keep the patient alive during the operation. Participants in the second group have a PVR procedure using an injectable self-expanding valve is used. This involves the replacement valve being placed in the correct position through a small incision (cut). The length of time that the participants stayed in hospital after their operation is recorded for all participants. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? Clinical Trials and Evaluation Unit, Bristol Royal Infirmary (UK) When is the study starting and how long is it expected to run for? February 2016 to February 2018 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Miss Rachel Heys

Critère d'inclusion

• Topic: Children, Cardiovascular disease; Subtopic: All Diagnoses, Cardiovascular (all Subtopics); Disease: All Diseases, Congenital Heart Disease and Pulmonary Hypertension

Liens

• isrctn
• ictrp