COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

Inclusion Criteria:

1. Weight ≥ 20 kg (44 lbs.)

2. Dysfunctional RVOT conduit or previously implanted valve in the pulmonic positionwith a clinical indication for intervention and with a landing zone diameter ≥ 16.5mm and ≤ 29 mm immediately prior to study device insertion as per the Instructionsfor Use

3. Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.

4. The subject/subject's legally authorized representative has been informed of thenature of the study, agrees to its provisions and has provided written informedconsent.

Exclusion Criteria:

1. Active infection requiring current antibiotic therapy (if temporary illness, subjectmay be a candidate 2 weeks after discontinuation of antibiotics)

2. History of or active endocarditis (active treatment with antibiotics) within thepast 180 days

3. Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder

4. Inappropriate anatomy for femoral introduction and delivery of the study valve

5. Need for concomitant atrial septal defect or ventricular septal defect closure orother concomitant interventional procedures other than pulmonary artery or branchpulmonary artery stenting or angioplasty

6. Angiographic evidence of coronary artery compression that would result fromtranscatheter pulmonic valve implantation (TPVI)

7. Interventional/surgical procedures within 30 days prior to the TPVI procedure.

8. Any planned surgical, percutaneous coronary or peripheral procedure to be performedwithin the 30 day follow-up from the TPVI procedure.

9. History of or current intravenous drug use

10. Major or progressive non-cardiac disease resulting in a life expectancy of less thanone year

11. Known hypersensitivity to aspirin or heparin and cannot be treated with otherantiplatelet and/or antithrombotic medications

12. Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot beadequately premedicated

13. Participating in another investigational drug or device study that has not reachedits primary endpoint.

14. Female who is lactating or pregnant