Harmony TPV EMEA PMS

Inclusion Criteria:

1. Subject eligible to receive Harmony TPV System in conformity with Instructions forUse (IFU) and local regulations at time of study enrollment.

2. Subject or subject's parent(s)/legal guardian(s) must be willing and able to consentto participate in the study and will commit to completion of all follow-uprequirements

Exclusion Criteria:

1. Obstruction of the central veins.

2. Planned concomitant branch pulmonary artery stenting at time of implant.

3. Subjects previously treated with an RV-PA conduit or previously implantedbioprosthesis.

4. 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.

5. Planned implantation of the Harmony TPV in the left heart.

6. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.

7. Pre-existing prosthetic heart valve or prosthetic ring in any position

8. Subject is pregnant as confirmed by a positive pregnancy test before implantprocedure for female subjects of childbearing potential.

9. Subjects that are vulnerable as defined in the Section 10.5 Subject Consent

Subject Consent Section excerpt:

• Vulnerable adults, defined as subjects incapable of giving consent, as assessed perInvestigator's opinion and in consideration of vulnerable adult definition per ISO 14155, will not be included in this study.

• Any subject with mental incompetence (e.g. Alzheimer's, dementia, psychiatricdisorders, developmental disorders, chromosomal abnormalities with associatedcognitive impairment) should be assessed by the Investigator for vulnerable status.If pediatric or adult subject is deemed by the Investigator mentally incompetent asdescribed above, the subject will not be included in this study.