Observational Study of Venus P-Valve

NCT05835349 · tracked via the Priya Life Science UK tracker

Sponsor

Venus MedTech (HangZhou) Inc.

Phase

Observational

Started

2024-08-26

Last updated

2025-01-24

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

Sex

ALL

Min age

12 Years

Max age

70 Years

Healthy volunteers

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 the UK