Observational study of the Venus P-Valve for treating heart valve issues
A Real-World Evidence Observational Study of VenusP-ValveTM System in the Treatment of Patients with Native RVOT Dysfunction
Venus MedTech (HangZhou) Inc. · NCT05835349
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 12 Years to 70 Years |
| Sex | All |
| Sponsor | Venus MedTech (HangZhou) Inc. (industry) |
| Locations | 10 sites (Pessac, New Aquitaine and 9 other locations) |
| Trial ID | NCT05835349 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise with similar transcatheter valve interventions, indicating a potential for success in this approach.
Eligibility criteria
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 this trial is running
Pessac, New Aquitaine and 9 other locations
- CHU Bordeaux — Pessac, New Aquitaine, France (NOT_YET_RECRUITING)
- 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)
- Heart CenterMunich — Munich, Bavaria, Germany (NOT_YET_RECRUITING)
- Clinic of Congenital Heart Disease — Berlin, State of Berlin, Germany (NOT_YET_RECRUITING)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Right Ventricular Outflow Tract Dysfunction