Ensayos clínicos

Inclusion Criteria:

1. Weight ≥ 25kg (55 lbs.)

2. Age ≥ 12 years old

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:

1) For symptomatic patients, fitting the following criteria:

- 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/m^2 or RVESVI ≥ 75 mL/m^2 or 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.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/31/23. Questions regarding updates should be directed to the study team contact.