Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction

Inclusion Criteria: 1. A symptomatic or appropriate asymptomatic subject with a native or repaired right ventricular outflow tract requiring reconstruction with a valved conduit 2. Age ≥5 years at the time of informed consent signature. Note: Additional Inclusion Criteria may apply Exclusion Criteria: 1. An artificial valve at another position or will need an artificial valve at another position (i.e. replacement at the time of index procedure or anticipated within 3 years). 2. Subjects with previously implanted pacemaker (including defibrillators). 3. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year. Note: Additional Exclusion Criteria may apply