Study of the Native Outflow Tract Transcatheter Pulmonary Valve (TPV)

Inclusion Criteria: * Subject has pulmonary regurgitation as per one or more of the following criteria: Severe pulmonary regurgitation as measured by Doppler echocardiography, or Pulmonary regurgitant fraction ≥ 30% as measured by cardiac magnetic resonance imaging * Clinical indication for surgical placement of a RVOT conduit or bioprosthetic pulmonary valve per one or more of the following criteria: Subject is symptomatic secondary to pulmonary insufficiency (e.g. exercise intolerance, fluid overload) as classified by the Investigator, or Right ventricular end diastolic volume (RVEDV) ≥ 150 ml/m2 * Subject is willing to consent to participate in the study and will commit to completion of all follow-up requirements Exclusion Criteria: * Anatomy unable to accommodate a 25 Fr delivery system * Obstruction of the central veins * Clinical or biological signs of infection including active endocarditis * Indicated for intervention of stenosis of the branch pulmonary arteries at time of implant * Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female subjects of child bearing potential * Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with a right ventricle-to-pulmonary artery conduit implant * A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year * Planned implantation of the Native Outflow Tract TPV in the left heart * RVOT anatomy or morphology that is unfavorable for anchoring * Known allergy to aspirin, heparin, or nickel * Echocardiographic evidence of intracardiac mass, thrombus, or vegetation * Pre-existing prosthetic heart valve or prosthetic ring in any position * Patient is currently enrolled in another investigational device or drug trial that may influence the outcome of this trial.