Real-world evidence, retrospective and prospective, non-randomized, multicenter observational study of VenusP-ValveTM System in treating moderate or greater pulmonary regurgitation with/without pulmonary stenosis in patients with native right ventricular outflow tract (RVOT).

All subjects will be followed up through five years for the observed outcome measures, which will be analyzed and reported to regulatory authorities as required.

Post-procedure, a clinical visit will be scheduled at discharge, thirty days, six months, one year, and annually thereafter to five years.

Inclusion Criteria

1. Patients with native RVOT (including transvalvular patch repair) are present with moderate or greater pulmonary regurgitation with/without stenosis and are clinically indicated for pulmonary valve intervention.
2. The patient (or the patient's legally authorized representative) is willing to consent to participate in the study and will commit to completing all follow-up requirements.

Exclusion Criteria:

1. Patients with any condition contraindicated by the IFU or inability to comply with the Venus P-ValveTM System Instructions for Use or the study protocol.

Baseline enrolment criteria

• 12 years old up to 70 years old
• Weight ≥ 30kg
• With evidence of moderate or severe (≥3+) pulmonary regurgitation by Transthoracic Echocardiography (TTE)
• With >30% pulmonary regurgitation fraction as defined by cardiac Magnetic Resonance Imaging (MRI)
• The subject is symptomatic from his/her pulmonary regurgitation or meets MRI criteria for intervention Right Ventricular Ejection Fraction (RVEF) < 45%, Pulmonary Regurgitant Fraction (PRRF) >30% and increased Right Ventricular End Diastolic Volume (RVEDV) Index (RVEDVI) >150mL/m²

Under attention to laws and regulations concerning personal data protection, empirical (non personally identifiable) data is anticipated to be shared within the clinical investigator team. Processed and analysed data would be shared within a wider community of medical professionals through professional conference presentations and peer-reviewed journal publications.