VenusP-Valve Pivotal Study (PROTEUS STUDY)

Eligibility Criteria

• 1. Weight ≥25kg (55 lbs.)
• 2. Age ≥ 12 years olds
• 3. Patients have a dysfunctional native RVOT with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography or pulmonary regurgitant fraction ≥30% as determined by cardiac magnetic resonance imaging) and without significant pulmonary stenosis (significant pulmonary stenosis is defined as gradient more than 25mmHg) and are clinically indicated for intervention:
• * Severe pulmonary regurgitation measured by echocardiogram or pulmonary regurgitant fraction ≥30% measured by CMR 2) For asymptomatic patients, including any 2 of the following criteria:
• * Mild or moderate RV or LV systolic dysfunction.
• * Severe RV dilation (RVEDVI ≥145 mL/m2 or RVESVI ≥ 75 mL/m2or RVEDV \>2 × LVEDV).
• * Progressive reduction in objective exercise tolerance. 4. Patient is willing to consent to participate in the study and will commit to completion of all follow-up requirements.
• 1. Clinical or biological signs of infection including active endocarditis.
• 2. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
• 3. Leukopenia, anemia, thrombocytopenia, or any known blood clotting disorder, deemed clinically significant after consultation with Haemato-oncology specialists.
• 4. Inappropriate anatomy for femoral or right internal jugular vein (RIJ) introduction and delivery of the VenusP-ValveTM System.
• 5. RVOT anatomy or morphology that is unfavorable for device anchoring.
• 6. Anatomy unable to accommodate VenusP-Valve delivery system.
• 7. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonary valve replacement (TPVR).
• 8. Emergency interventional/surgical procedures within 30 days prior to the index procedure.
• 9. Planned significant and relevant concomitant procedure at time of VenusP-Valve implant.
• 10. Any planned interventional/surgical procedures to be performed within the 30 days follow-up from VenusP-Valve implant.
• 11. Known history of intravenous drug abuse in the past 5 years, without certificate of completion of rehabilitation from a specialist.
• 12. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year.
• 13. Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or nitinol (titanium or nickel) leading to be unable to undergo index procedure per physicians' judgement
• 14. Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female patients of child-bearing potential.
• 15. Currently participating in an investigational drug or another device study.
• 16. Patient or guardian unwilling or unable to provide written informed consent or comply with follow-up requirements.
• 17. The investigators consider that the patients are not suitable to participate in this research.