Clinical Trials in Italy / NCT05835349
Recruiting
Observational
Observational Study of Venus P-Valve
NCT05835349 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Right Ventricular Outflow Tract Dysfunction
Investigational drug(s) / intervention(s)
transcatheter pulmonary valve implantation (TPVI)
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.
Study 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).
Eligibility
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.
Primary outcome measure(s)
- Non-hierarchical composite endpoint — at six months
* Freedom from VenusP-ValveTM (catheter or surgical) reintervention * Acceptable hemodynamic function, defined as: 1. Mild or less regurgitation measured by echocardiography; AND 2. Mean RVOT gradient as measured by echocardiography ≤35mmHg.
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU Bordeaux | Pessac | New Aquitaine | Not Yet Recruiting |
| Chu Nantes | Nantes | Pays de la Loire Region | Recruiting |
| Marie Lannelongue | Le Plessis-Robinson | Île-de-France Region | Recruiting |
| Hopital Necker-Enfants malades | Paris | Île-de-France Region | Recruiting |
| Heart CenterMunich | Munich | Bavaria | Not Yet Recruiting |
| Clinic of Congenital Heart Disease | Berlin | State of Berlin | Not Yet Recruiting |
| OPBG Rome | Rome | Lazio | Not Yet Recruiting |
| S. Donato Milan | Milan | Lombardy | Not Yet Recruiting |
| Leeds General Infirmary | Leeds | England | Not Yet Recruiting |
| Evelina Children's Hospital | London | England | Not Yet Recruiting |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05835349 on ClinicalTrials.gov ↗ ← All trials in Italy