Melody Transcatheter Pulmonary Valve (TPV) Post-Market Surveillance Study

Exclusion Criteria

• •Active endocarditis
• •A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year
• •Patient or - for patients who cannot legally give consent themselves- the 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
• •Known intravenous drug abuse