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RECRUITING
NCT05835349

Observational Study of Venus P-Valve

Sponsor: Venus MedTech (HangZhou) Inc.

View on ClinicalTrials.gov

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).

Official title: A Real-World Evidence Observational Study of VenusP-ValveTM System in the Treatment of Patients with Native RVOT Dysfunction

Key Details

Gender

All

Age Range

12 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2024-08-26

Completion Date

2032-12

Last Updated

2025-01-24

Healthy Volunteers

No

Interventions

DEVICE

transcatheter pulmonary valve implantation (TPVI)

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

Locations (10)

CHU Bordeaux

Pessac, Nouvelle-Aquitaine, France

Chu Nantes

Nantes, Pays de la Loire Region, France

Marie Lannelongue

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

Hopital Necker-Enfants malades

Paris, Île-de-France Region, France

Heart CenterMunich

Munich, Bavaria, Germany

Clinic of Congenital Heart Disease

Berlin, State of Berlin, Germany

OPBG Rome

Rome, Lazio, Italy

S. Donato Milan

Milan, Lombardy, Italy

Leeds General Infirmary

Leeds, England, United Kingdom

Evelina Children's Hospital

London, England, United Kingdom