Recruiting

VenusP-Valve

Sponsor:

Venus MedTech (HangZhou) Inc.

Code:

NCT06010563

Conditions

Pulmonary Regurgitation

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Transcatheter pulmonary valve implantation (TPVI)

VenusP-ValveTM System

Study Details

Brief summary:

A prospective, multi-center, non-randomized interventional study to evaluate the safety and effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction.

Post procedure, a clinical visit will be scheduled at pre-discharge, 30 days, 6 months, 12 months, and annually thereafter to 10 years.

About 60 subjects will be enrolled in this study. Data analysis will be performed after all enrolled subjects complete 6-month follow-up and the primary endpoint analysis report will be submitted to FDA for PMA approval.

Conditions

Pulmonary Regurgitation

Study ID

NCT06010563

Start date

Jun 11, 2024

Status verified date

Feb, 2025

Completion date

Aug 30, 2034

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TPVI

Interventions

Transcatheter pulmonary valve implantation (TPVI)

A valve is implanted through a catheter (a narrow tube) and inserted through the femoral vein into the right atrium, right ventricle and pulmonary artery. After careful positioning, the valve is implanted by inflating a set of a balloons on the delivery catheter or self-expanding. After the catheter has been removed, the incision is closed with stitches, which are removed after the area has healed.

VenusP-ValveTM System

VenusP-ValveTM System consists of two components:

1. Transcatheter Pulmonary Valve (TPV)
2. Delivery System (DS) including Delivery Catheter System (DCS) and Compression Loading System (CLS) The TPV consists of a self-expanding nitinol stent with a single layer tri-leaflet porcine pericardium tissue.

For the Delivery Catheter System (DCS) , the distal (deployment) end of the system features an atraumatic, radiopaque tip. A protective sheath (capsule) covers and maintains the TPV in a crimped position. The handle at the proximal end of the catheter is used to load and deploy the TPV.

The CLS compresses the TPV into the catheter, which including capture tube, valve protection tube, tip support tube, loading mandrels and crimper.

Primary outcome measure

  • The rate of procedure or device related mortality at the 30 days follow-up visit post procedure [ Time Frame: At 30 Days Post Procedure ]
  • The rate of re-intervention and acceptable hemodynamic function at 6 Month follow-up visit post procedure [ Time Frame: At 6 Months Post Procedure ]

Central Contacts and Locations

Locations

Venusmedtech of America

Recruiting

Irvine, California, United States, 92618

More Information

Sponsor

Venus MedTech (HangZhou) Inc.

Last update posted

Feb 28, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Venus MedTech (HangZhou) Inc. on 2025-02-28.