VenusP-Valve Pivotal Study (PROTEUS STUDY)

NCT ID: NCT06010563

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-11
• Study Completion Date: 2034-08-30

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TPVI

Group Type: EXPERIMENTAL

Transcatheter pulmonary valve implantation (TPVI)

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Venus MedTech (HangZhou) Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Venusmedtech of America

Irvine, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cong Ma

Role: CONTACT

macong@venusmedtech.com

+8618817939751

Facility Contacts

Frank Zeng

Role: primary

Other Identifiers

VTPR-22-07

Identifier Type: -

Identifier Source: org_study_id