Observational Study of Venus P-Valve
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcatheter pulmonary valve implantation (TPVI).
- Who it may be relevant to
- Registry conditions: Right Ventricular Outflow Tract Dysfunction. Basic parameters: 12 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Germany, Italy, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Real-World Evidence Observational Study of VenusP-ValveTM System in the Treatment of Patients with Native RVOT Dysfunction
Overview
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).
Detailed description
All subjects will be followed up through five years for the observed outcome measures, which will be analyzed and reported to regulatory authorities as required.
Post-procedure, a clinical visit will be scheduled at discharge, thirty days, six months, one year, and annually thereafter to five years.
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.
Primary outcome measures
- Non-hierarchical composite endpoint [Time frame: at six months]
Secondary outcome measures (4)
- Procedural Success [Time frame: at 30 days]
- Occurrence of Events [Time frame: through five years]
- Functional status [Time frame: through five years]
- Health-state utility score [Time frame: through five years]
Eligibility criteria
Inclusion criteria
- 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 4 centers
- CHU Bordeaux — Pessac
- Chu Nantes — Nantes
- Marie Lannelongue — Le Plessis-Robinson
- Hopital Necker-Enfants malades — Paris
Germany · 2 centers
- Heart CenterMunich — Munich
- Clinic of Congenital Heart Disease — Berlin
Italy · 2 centers
- OPBG Rome — Rome
- S. Donato Milan — Milan
United Kingdom · 2 centers
- Leeds General Infirmary — Leeds
- Evelina Children's Hospital — London
Identifiers
NCT: NCT05835349 · VTPR-22-08