Melody Transcatheter Pulmonary Valve (TPV) Study: Post Approval Study of the Original Investigational Device Exemption (IDE) Cohort

Inclusion Criteria:

- Age greater than or equal to 5 years of age

- Weight greater than or equal to 30 kilograms

- Existence of a full (circumferential) RVOT conduit that was equal to or greater than
16 mm in diameter when originally implanted, or a stented bioprosthesis with a rigid
circumferential sewing ring in the RVOT that has an internal diameter greater than or
equal to 18 mm and less than or equal to 22 mm when originally implanted.

- Any of the following by transthoracic echocardiography:

- For patients in New York Heart Association (NYHA) Classification II, III, or IV:
Moderate (3+) or severe (4+) pulmonary regurgitation AND/OR Mean RVOT gradient greater
than or equal to 35 mmHg

- For patients in NYHA Classification I:Severe (4+) pulmonary regurgitation with RV
dilatation or dysfunction AND/OR Mean RVOT gradient greater or equal to 40 mmHg

Exclusion Criteria:

- Active endocarditis

- Major or progressive non-cardiac disease (liver failure, renal failure, cancer)that
has a life expectancy of less than one year

- Patient or guardian unwilling or unable to provide written informed consent or comply
with follow-up requirements

- Obstruction of the central veins (including the superior and inferior vena cava,
bilateral iliac veins) such that the delivery system cannot be advanced to the heart
via transvenous approach from either femoral vein or internal jugular vein

- Positive urine or serum pregnancy test 24 hours prior to procedure in female patients
of child bearing potential

- Known intravenous drug abuse