Clinical Research Directory

Inclusion Criteria: 1. The candidate/candidate's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. 2. Weight is ≥ 20 kg (44 lbs). 3. RVOT/PV with moderate or greater PR by TTE. 4. RVOT/PV proximal and distal landing zone diameter ≥ 27 mm and ≤ 38 mm, and minimum of 35 mm from contractile tissue to lowest pulmonary artery takeoff. Exclusion Criteria: 1. Active infection requiring current antibiotic therapy (if temporary illness, patient may be a candidate 2 weeks after discontinuation of antibiotics). 2. History of or active endocarditis (active treatment with antibiotics) within the past 180 days. 3. Leukopenia (WBC \< 2000 cells/μL), anemia (Hgb \< 7 g/dL), thrombocytopenia (platelets \< 50,000 cells/μL) or any known blood clotting disorder. 4. Inappropriate anatomy for introduction and delivery of the Alterra Adaptive Prestent or the SAPIEN 3 THV. 5. Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty 6. Interventional/surgical procedures within 30 days prior to the Alterra or valve implant procedure 7. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the Alterra or valve implant procedure 8. History of or current intravenous drug use 9. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year 10. Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications 11. Known hypersensitivity to nitinol, cobalt-chromium, nickel or contrast media that cannot be adequately pre-medicated 12. Currently participating in an investigational drug or another device study \[Note: Trials requiring extended follow up for products that were investigational, but have since become commercially available, are not considered investigational devices.\] 13. Positive urine or serum pregnancy test in female patients of child-bearing potential 14. Renal insufficiency (creatinine \> 3.0 mg/dL) and/or renal replacement therapy