CorMatrix Cor TRICUSPID ECM Valve Replacement Study

This study evaluates a new type of tricuspid heart valve replacement made from natural tissue matrix material (CorMatrix ECM). The tricuspid valve is on the right side of the heart, and when it fails or leaks, it can cause serious health problems. This valve replacement is being tested as an alternative to mechanical valves, particularly in children born with congenital heart defects, with the hope that it will grow and adapt naturally in the body. You may be eligible if: - You have a tricuspid valve that is severely leaking or absent and requires surgery - You (or your child with congenital heart disease) are willing to attend follow-up visits You may NOT be eligible if: - Your tricuspid valve annulus (ring) is too small (under 10mm) for the replacement valve - Your heart ejection fraction is below 25% - Your pulmonary artery pressure is very high (above 50 mmHg) - You are in emergency cardiac surgery requiring resuscitation - You had a heart transplant or recent heart attack resulting in shock - You have serious liver disease, kidney failure (creatinine above 4.0), or a stroke in the last 30 days - You are known to be sensitive to porcine (pig) materials - You are pregnant Talk to your doctor to see if this trial is right for you.