Safety and Efficacy of the Adapt Pericardial Patch in the repair of defects associated with congenital heart disease in participants aged between 1 and 12 years of age

The Adapt Pericardial Patch (CardioCel) (4 x 4 cm) will be used for the repair of defects associated with Congenital Heart Disease. The research question is to assess whether the patch's integrity is maintained during follow-up (performation or aneurismal formation). CardioCel is comprised of tissue engineered bovine pericardium that is cross linked in diluted glutaraldehyde solution and treated with the ADAPT TEP technology. Only one size of CardioCel is available (4x4cm). CardioCel may be sutured or stapled in place. CardioCel is stored at room temperature, never below 5 degrees celcius or above 25 degrees celcius and away from direct heat source. The implant should not be re-sterilised. No extensive rinsing is required. The patch is immersed in sterile physiological saline to avoid dehydration of the patch prior to implantation. Implantation specifics will be determined at the time of surgery depending on the nature of the repair needed. In general, the surgeon may cut and shape CardioCel to suit the requirements of the procedure. Care needs to be taken when handling the device, for example by using atraumatic forceps, to avoid tearing or otherwise damaging the patch. The device needs to be examined for damage prior to implant. If one side of the patch appears smoother than the other, the device should be implanted with the smoother surface facing the blood flow surface. CardioCel may be cut, folded or layered as required. If layering, it is preferable to cut the material into separate sheets, creating edges rather than folding it, presenting the maximum number of cut surfaces to body tissue, to enhance penetration by cell and blood vessels. CardioCel may be sutured or stapled in place. It will hold sutures easily and firmly and will remain in situ whilst it is incorporated into surrounding tissues. Any unused pieces of CardioCel should be discarded. The solution in which the CardioCel is sterilised/stored should be disposed of using normal hospital chemical waste disposal methods. The surgical procedure time is dependent upon the severity of the condition being treated and any intra-operative complications that may occur. Routinely these type of procedures take approximately two hours.