Melody® Transcatheter Pulmonary Valve Post-Approval Study

Implantation of the Medtronic Melody Transcatheter Pulmonary Valve (TPV) in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Post-Market Approval Study

The purpose of this study is to confirm the short-term hemodynamic effectiveness results achieved by real-world providers are equivalent to the historical control established in the IDE study.

Inclusion Criteria:

• Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted
• Dysfunctional RVOT conduits with a clinical indication for intervention (regurgitation ≥ moderate regurgitation, Stenosis: mean RVOT gradient ≥ 35 mmHg)

Exclusion Criteria:

• Implantation in the aortic or mitral position
• Venous anatomy unable to accommodate a 22-fr size introducer sheath
• Obstruction of the central veins
• Clinical or biological signs of infection including active endocarditis
• Unwilling or unable to provide written informed consent or comply with the follow-up requirements