Observational Study of Venus P-Valve

NCT05835349 | Recruiting

• 1 other identifier: VTPR-22-08
• Study Type: observational
• Target: 200
• Locations: 4 countries
• Sites: 10

Brief Summary

Real-world evidence, retrospective and prospective, non-randomized, multicenter observational study of VenusP-ValveTM System in treating moderate or greater pulmonary regurgitation with/without pulmonary stenosis in patients with native right ventricular outflow tract (RVOT).

Conditions

Right Ventricular Outflow Tract Dysfunction

Outcome Measures

Primary Outcomes (1)

• Non-hierarchical composite endpoint

  * Freedom from VenusP-ValveTM (catheter or surgical) reintervention * Acceptable hemodynamic function, defined as: 1. Mild or less regurgitation measured by echocardiography; AND 2. Mean RVOT gradient as measured by echocardiography ≤35mmHg.

  at six months

Secondary Outcomes (4)

• Procedural Success

  at 30 days

• Occurrence of Events

  through five years

• Functional status

  through five years

• Health-state utility score

  through five years

Interventions

transcatheter pulmonary valve implantation (TPVI) DEVICE

A stent-mounted valve is introduced over a guidewire and positioned in the RVOT, followed by balloon inflation to deploy the valve.

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Baseline enrolment criteria * 12 years old up to 70 years old * Weight ≥ 30kg * With evidence of moderate or severe (≥3+) pulmonary regurgitation by Transthoracic Echocardiography (TTE) * With \>30% pulmonary regurgitation fraction as defined by cardiac Magnetic Resonance Imaging (MRI) * The subject is symptomatic from his/her pulmonary regurgitation or meets MRI criteria for intervention Right Ventricular Ejection Fraction (RVEF) \< 45%, Pulmonary Regurgitant Fraction (PRRF) \>30% and increased Right Ventricular End Diastolic Volume (RVEDV) Index (RVEDVI) \>150mL/m²

You may qualify if:

• Patients with native RVOT (including transvalvular patch repair) are present with moderate or greater pulmonary regurgitation with/without stenosis and are clinically indicated for pulmonary valve intervention.
• The patient (or the patient's legally authorized representative) is willing to consent to participate in the study and will commit to completing all follow-up requirements.

You may not qualify if:

• \. Patients with any condition contraindicated by the IFU or inability to comply with the Venus P-ValveTM System Instructions for Use or the study protocol.

Sponsors & Collaborators

• Venus MedTech (HangZhou) Inc.: lead
• IQVIA MedTech BV of Antwerp, Belgium: collaborator
• MDCECRO LLC: collaborator

Study Sites (10)

CHU Bordeaux

Pessac, Nouvelle-Aquitaine, 33600, France

NOT YET RECRUITING

Chu Nantes

Nantes, Pays de la Loire Region, 44093, France

RECRUITING

Marie Lannelongue

Le Plessis-Robinson, Île-de-France Region, 92350, France

RECRUITING

Hopital Necker-Enfants malades

Paris, Île-de-France Region, 75015, France

RECRUITING

Heart CenterMunich

Munich, Bavaria, 81377, Germany

NOT YET RECRUITING

Clinic of Congenital Heart Disease

Berlin, State of Berlin, 13353, Germany

NOT YET RECRUITING

OPBG Rome

Rome, Lazio, 165, Italy

NOT YET RECRUITING

S. Donato Milan

Milan, Lombardy, 20097, Italy

NOT YET RECRUITING

Leeds General Infirmary

Leeds, England, LS1 3EX, United Kingdom

NOT YET RECRUITING

Evelina Children's Hospital

London, England, SE1 7EH, United Kingdom

NOT YET RECRUITING

Study Officials

• Shakeel A. Qureshi, MD

  Evelina Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cong Ma

CONTACT

+86 18817939751; macong@venusmedtech.com

Ping Zhang

CONTACT

15802168031; zhangping@venusmedtech.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: August 26, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2032
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); GB (2); IT (2); DE (2)