Cristiano Spadaccio, MD
Surgery
Phase 2
Cor TRICUSPID ECM Valve Study
This study checks the safety and performance of the Cor TRICUSPID ECM Valve (and a pediatric version) when used to replace a broken or leaking tricuspid heart valve. Adults and children who need surgical tricuspid valve replacement may take part. Before surgery participants have a baseline check, then they get the valve implanted during open heart surgery. Follow-up exams happen at hospital discharge, 30 days, 6 months, 12 months, and then every year up to 5 years. The study will track whether the valve is implanted successfully, whether it works to reduce valve leakage and improve symptoms, and whether there are device‑related complications such as infection, valve failure, or need for another procedure.