VenusP-Valve Pivotal Study (PROTEUS STUDY)

NCT06010563 | Recruiting DMC FDA Device

• 1 other identifier: VTPR-22-07
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• The rate of procedure or device related mortality at the 30 days follow-up visit post procedure

  Freedom from procedure or device related mortality at 30 days

  At 30 Days Post Procedure

• The rate of re-intervention and acceptable hemodynamic function at 6 Month follow-up visit post procedure

  Freedom from VenusP-Valve re-intervention and acceptable hemodynamic function at 6 months defined as: 1. No more than mild regurgitation measured by CMR; AND 2. Mean RVOT gradient as measured by echocardiography ≤35mmHg.

  At 6 Months Post Procedure

Secondary Outcomes (7)

• The rate of all-cause mortality, procedure or device related mortality, and procedure or device related Major Adverse Cardiac and Cerebrovascular Events (MACCE) out to 10 years

  Through Ten Years Post Procedure

• The rate of technical Success during the procedure

  During the Procedure

• The rate of acceptable hemodynamic performance at 30 days, 1-5 years, 7 years and 10 years.

  At 30 Days, 1-5 Years, 7 Years and 10 Years Post Procedure

• The rate of procedure success out to 30 days

  At 30 Days Post Procedure

• The rate of valve dysfunction out to 10 years

  Through Ten Years Post Procedure

Study Arms (1)

TPVI

EXPERIMENTAL

Device: Transcatheter pulmonary valve implantation (TPVI); Device: VenusP-ValveTM System

Interventions

Transcatheter pulmonary valve implantation (TPVI) 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.

TPVI

VenusP-ValveTM System 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.

TPVI

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Weight ≥25kg (55 lbs.)
• Age ≥ 12 years olds
• 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:
• \) 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.

You may not qualify if:

• Clinical or biological signs of infection including active endocarditis.
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
• Leukopenia, anemia, thrombocytopenia, or any known blood clotting disorder, deemed clinically significant after consultation with Haemato-oncology specialists.
• Inappropriate anatomy for femoral or right internal jugular vein (RIJ) introduction and delivery of the VenusP-ValveTM System.
• RVOT anatomy or morphology that is unfavorable for device anchoring.
• Anatomy unable to accommodate VenusP-Valve delivery system.
• Angiographic evidence of coronary artery compression that would result from transcatheter pulmonary valve replacement (TPVR).
• Emergency interventional/surgical procedures within 30 days prior to the index procedure.
• Planned significant and relevant concomitant procedure at time of VenusP-Valve implant.
• Any planned interventional/surgical procedures to be performed within the 30 days follow-up from VenusP-Valve implant.
• Known history of intravenous drug abuse in the past 5 years, without certificate of completion of rehabilitation from a specialist.
• Major or progressive non-cardiac disease resulting in a life expectancy of less than one year.
• Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or nitinol (titanium or nickel) leading to be unable to undergo index procedure per physicians' judgement
• Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female patients of child-bearing potential.
• Currently participating in an investigational drug or another device study.

Sponsors & Collaborators

• Venus MedTech (HangZhou) Inc.: lead

Study Sites (1)

Venusmedtech of America

Irvine, California, 92618, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Cong Ma

CONTACT

+8618817939751; macong@venusmedtech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 24, 2023
• Study Start: June 11, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2034
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)