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

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.