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

The purpose of this study is to demonstrate the safety and effectiveness of the Edwards
Lifesciences SAPIEN 3 THV System in subjects with a dysfunctional RVOT conduit or previously
implanted valve in the pulmonic position with a clinical indication for intervention.

Inclusion Criteria:

- Weight ≥ 20 kg (44 lbs.)

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

- The subject/subject's legally authorized representative has been informed of the
nature of the study, agrees to its provisions and has provided written informed
consent.

Exclusion Criteria:

- Active infection requiring current antibiotic therapy (if temporary illness, subject
may be a candidate 2 weeks after discontinuation of antibiotics)

- History of or active endocarditis (active treatment with antibiotics) within the past
180 days

- Leukopenia (WBC < 2000 cells/µL), anemia (Hgb < 7 g/dL), thrombocytopenia (Platelets <
50,000 cells/µL) or any known blood clotting disorder

- Inappropriate anatomy for femoral introduction and delivery of the SAPIEN 3 THV