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Observational Study of Venus P-Valve
Sponsor: Venus MedTech (HangZhou) Inc.
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
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