Actively Recruiting

Age: 12Years - 70Years
All Genders
NCT05835349

Observational Study of Venus P-Valve

Led by Venus MedTech (HangZhou) Inc. · Updated on 2025-01-24

200

Participants Needed

10

Research Sites

431 weeks

Total Duration

On this page

Sponsors

V

Venus MedTech (HangZhou) Inc.

Lead Sponsor

I

IQVIA MedTech BV of Antwerp, Belgium

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Observational Study of Venus P-Valve

Who Can Participate

Age: 12Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with native RVOT (including transvalvular patch repair) who have moderate or greater pulmonary regurgitation with or without stenosis and are clinically indicated for pulmonary valve intervention.
  • Patient or legally authorized representative willing to consent and able to complete all follow-up requirements.
Not Eligible

You will not qualify if you...

  • Patients with any condition that contraindicates use of the Venus P-ValveTM System or prevents compliance with its Instructions for Use or the study protocol.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

CHU Bordeaux

Pessac, New Aquitaine, France, 33600

Not Yet Recruiting

2

Chu Nantes

Nantes, Pays de la Loire Region, France, 44093

Actively Recruiting

3

Marie Lannelongue

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

Actively Recruiting

4

Hopital Necker-Enfants malades

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

Actively Recruiting

5

Heart CenterMunich

Munich, Bavaria, Germany, 81377

Not Yet Recruiting

6

Clinic of Congenital Heart Disease

Berlin, State of Berlin, Germany, 13353

Not Yet Recruiting

7

OPBG Rome

Rome, Lazio, Italy, 165

Not Yet Recruiting

8

S. Donato Milan

Milan, Lombardy, Italy, 20097

Not Yet Recruiting

9

Leeds General Infirmary

Leeds, England, United Kingdom, LS1 3EX

Not Yet Recruiting

10

Evelina Children's Hospital

London, England, United Kingdom, SE1 7EH

Not Yet Recruiting

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Research Team

C

Cong Ma

CONTACT

P

Ping Zhang

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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