Observational study of the Venus P-Valve for treating heart valve issues
Official title: A Real-World Evidence Observational Study of VenusP-ValveTM System in the Treatment of Patients with Native RVOT Dysfunction
Run by Venus MedTech (HangZhou) Inc. · NCT05835349 · Data updated 2026-11-12
This study is testing how well the Venus P-Valve can help people with heart valve problems related to pulmonary regurgitation and stenosis over a five-year period.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 12 Years to 70 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Venus MedTech (HangZhou) Inc. Industry-sponsored |
| Locations | 10 sites (Pessac, New Aquitaine and 9 other locations) |
| Status | Recruiting |
| Started | August 26, 2024 |
| Main results expected | August 2026 |
| Study ends | December 2032 |
| Registry record updated | January 24, 2025 |
| Trial ID | NCT05835349 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with native right ventricular outflow tract dysfunction and moderate or greater pulmonary regurgitation who are indicated for pulmonary valve intervention.
✕Probably not a fit
Patients with conditions that contraindicate the use of the Venus P-Valve or those unable to comply with the study protocol may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the effectiveness of the Venus P-Valve System in patients with moderate or greater pulmonary regurgitation, with or without pulmonary stenosis, affecting the right ventricular outflow tract. It includes both retrospective and prospective data collection from multiple centers, following patients for up to five years. Participants will undergo transcatheter pulmonary valve implantation and will have scheduled follow-up visits at various intervals to assess outcomes.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with significant pulmonary regurgitation, potentially improving their heart function and quality of life.
How similar studies have gone: Other studies have shown promise with similar transcatheter valve interventions, indicating a potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Chu Nantes
Nantes, Pays de la Loire Region, France Recruiting -
Marie Lannelongue
Le Plessis-Robinson, Île-de-France Region, France Recruiting -
Hopital Necker-Enfants malades
Paris, Île-de-France Region, France Recruiting -
CHU Bordeaux
Pessac, New Aquitaine, France Not yet recruiting -
Heart CenterMunich
Munich, Bavaria, Germany Not yet recruiting -
Clinic of Congenital Heart Disease
Berlin, State of Berlin, Germany Not yet recruiting
Show 4 more locations
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OPBG Rome
Rome, Lazio, Italy Not yet recruiting -
S. Donato Milan
Milan, Lombardy, Italy Not yet recruiting -
Leeds General Infirmary
Leeds, England, United Kingdom Not yet recruiting -
Evelina Children's Hospital
London, England, United Kingdom Not yet recruiting
Study contacts
- Principal investigator: Shakeel A. Qureshi, MD — Evelina Children's Hospital
- Study coordinator: Cong Ma
- Email: macong@venusmedtech.com
- Phone: +86 18817939751
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.