Evaluation of the VenusP-Valve for treating pulmonary regurgitation

Evaluation of the Performance of the VenusP-ValveTM System in Patients with Native RVOT Dysfunction

This study is testing a new valve to see if it can safely help people with severe pulmonary regurgitation feel better after a heart procedure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Venus MedTech (HangZhou) Inc. (Industry-sponsored)
• Locations: 1 site (Irvine, California)
• Trial ID: NCT06010563 on ClinicalTrials.gov

What this trial studies

This interventional study aims to assess the safety and effectiveness of the VenusP-ValveTM System in patients suffering from dysfunction of the right ventricular outflow tract (RVOT) due to severe pulmonary regurgitation. It will enroll approximately 60 subjects who will undergo transcatheter pulmonary valve implantation (TPVI) and will be monitored through clinical visits at various intervals post-procedure, including pre-discharge and at 30 days, 6 months, 12 months, and annually for up to 10 years. The primary endpoint analysis will be submitted to the FDA for approval after all subjects complete their 6-month follow-up.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 12 years and older, weighing at least 25 kg, with severe pulmonary regurgitation and dysfunctional native RVOT.

Not a fit: Patients with significant pulmonary stenosis or those who do not meet the inclusion criteria for severe pulmonary regurgitation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with severe pulmonary regurgitation, potentially improving their quality of life and cardiac function.

How similar studies have performed: Other studies involving transcatheter pulmonary valve implantation have shown promising results, indicating that this approach may be effective for similar conditions.

Eligibility criteria

Inclusion 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:

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/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.

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.

Where this trial is running

Irvine, California

• Venusmedtech of America — Irvine, California, United States (Recruiting)

Study contacts

• Study coordinator: Cong Ma

Conditions Pulmonary Regurgitation