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Observational Study of Venus P-Valve

Recruitingn/aAges 12 Years - 70 YearsAllVenus MedTech (HangZhou) Inc.
NCT05835349 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
Inclusion Criteria 1. 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. 2. 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. Exclusion Criteria: 1\. 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.
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What it tests

  • transcatheter pulmonary valve implantation (TPVI)
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Where

10 sites
CHU Bordeaux
Pessac, France
Chu Nantes
Nantes, France
Marie Lannelongue
Le Plessis-Robinson, France
Hopital Necker-Enfants malades
Paris, France
Heart CenterMunich
Munich, Germany
Clinic of Congenital Heart Disease
Berlin, Germany
OPBG Rome
Rome, Italy
S. Donato Milan
Milan, Italy

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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