COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction

The study is a prospective, non-randomized, multi-center clinical study to assess the safety
and effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional
RVOT conduits requiring treatment for moderate or severe pulmonary regurgitation (PR) by
transthoracic echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of
≥ 35 mmHg by TTE.

Inclusion Criteria:

1. Patient has a dysfunctional, non-compliant RVOT conduit.

2. The patient/patient'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:

1. Inability to tolerate an anticoagulation/antiplatelet regimen

2. Active bacterial endocarditis