PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

Inclusion Criteria: * Body weight greater than or equal to 30 kilograms * Pulmonary regurgitation moderate or severe pulmonary regurgitation or pulmonary valve stenosis with mean gradient \>35mmHg by echocardiography * Main pulmonary artery trunk of ≥16 mm and ≤30 mm * Patients willing to provide written informed consent and comply with follow-up evaluations. Exclusion Criteria: * Females of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant up until 6 months after TPV implantation * Pre-existing mechanical valve in pulmonary position or require concomitant repair of other cardiac valves * Obstruction of the central veins to be approached for the TPV implantation * Coronary artery compression confirmed by angiography * A known severe allergy to Nickel * A known hypersensitivity to any anticoagulation therapy, contrast agent or a hemorrhagic disease * Suspected active infectious disease (e.g. endocarditis, meningitis) * Life expectancy of less than 6 months