A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Transcatheter Pulmonary Valve (TPV)

Inclusion Criteria: * Age greater than or equal to 10 years of age * Body weight greater than or equal to 30 kilograms * Pulmonary regurgitation ≥moderate pulmonary regurgitation (PR) (≥3+) or RVOT conduit obstruction with mean gradient \>35mmHg by echocardiography * pulmonary artery annulus or in situ conduit size ≥16 and ≤26mm * Patient willing to provide written informed consent and comply with follow-up requirements Exclusion Criteria: * Pre-existing mechanical heart valve in any position * Obstruction of the central veins (pulmonic bioprosthesis delivery system to the heart) * Coronary artery compression * A known hypersensitivity to Aspirin or Heparin * Immunosuppressive disease * Active infectious disease (e.g. endocarditis, meningitis) * Estimated survival less than 6 months * Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.