COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV

The study design is a multi-center, prospective, non-randomized study of up to 70 implanted
subjects (US) with no site representing more than 30% of the implanted subjects. The subjects
will include those subjects who have previously undergone placement of a conduit between the
right ventricle and pulmonary artery and now present with a dysfunctional RVOT conduit
requiring treatment for moderate or severe pulmonary regurgitation and/or RVOT conduit
obstruction.

Inclusion Criteria

1. Weight must be equal to or exceed 35 kilograms.

2. In situ conduit size of ≥ 16 mm and ≤ 24 mm in diameter.

3. Subject presents with moderate or severe pulmonary regurgitation defined as ≥3+
pulmonary regurgitation by TTE or RVOT conduit obstruction with a mean gradient of >=
35 mmHg by TTE.

4. Subject is symptomatic as evidenced by cardiopulmonary exercise testing.

5. The subject or the subject's legal representative has been informed of the nature of
the study, agrees to its provisions and has provided written informed consent as
approved by the Institutional Review Board (IRB) of the respective clinical site.

6. The subject and the treating physician agree that the subject will return for all
required post-procedure follow up visits and the subject will comply with
protocol-required follow-up visits.

7. Catheterization is determined to be feasible by the treating physician.

Exclusion Criteria

1. Active infection requiring current antibiotic therapy (if temporary illness, subject
may be a candidate 4 weeks after discontinuation of antibiotics)

2. Previously enrolled in this study.

3. Subject with pre-existing prosthetic heart valves in any position*.

4. Severe chest wall deformity.

5. Leukopenia (WBC<3000 mm3).

6. Acute or chronic anemia (Hb <9 g/dL).