VenusP-Valve Pivotal Study (PROTEUS STUDY)

Exclusion Criteria

• •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.