Harmony TPV Post-Approval Study

Harmony TPV Post-Approval Study (Harmony PAS2)

The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.

Inclusion Criteria:

• Patient eligible to receive the Harmony TPV, meeting the indications for use criteria per current geography-specific device labeling at time of study enrollment
• Patient (or patient's legally authorized representative) is willing to consent to participate in the study

Exclusion Criteria:

• Obstruction of the central veins
• Planned concomitant branch pulmonary artery stenting at time of implant
• Subject is pregnant at time of implant procedure
• Patients with previously treated with an RV-PA conduit or previously implanted bioprosthesis
• 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
• Planned implantation of the Harmony TPV in the left heart
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
• Pre-existing prosthetic heart valve or prosthetic ring in any position