Observational Study of Venus P-Valve

Recruiting

• Conditions: Right Ventricular Outflow Tract Dysfunction

• Registration Number: NCT05835349
• Lead Sponsor: Venus MedTech (HangZhou) Inc.

Brief 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).

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.

Study Timeline

• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-28
• Study Start: 2024-08-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-24
• Primary Completion: 2026-08
• Study Completion: 2032-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Health-state utility score	through five years	Health-state utility score as measured by the EQ-5D at pre-implant, 30 days, 6 months, 1 year and annually thereafter through 5 years.
Procedural Success	at 30 days	Procedure success at 30 days, defined as: * Freedom from procedure/device-related mortality; * Freedom from Venus P-ValveTM (catheter or surgical) reintervention concerning index procedure or device; * Acceptable hemodynamic function; * Original intended valve in situ
Occurrence of Events	through five years	Occurrence of the following events through 5 years of follow-up: * All-cause mortality and procedure/device-related mortality; * Venus P-ValveTM (catheter or surgical) reintervention; * Venus P-ValveTM dysfunction; * Serious procedure/device-related adverse events
Functional status	through five years	New York Heart Association (NYHA) classification out to 5 years

Trial Locations

Locations (10)

CHU Bordeaux; 🇫🇷 Pessac, Nouvelle-Aquitaine, France

Chu Nantes; 🇫🇷 Nantes, Pays de la Loire, France

Marie Lannelongue; 🇫🇷 Le Plessis-Robinson, Île-de-France, France

Hopital Necker-Enfants malades; 🇫🇷 Paris, Île-de-France, France

Heart CenterMunich; 🇩🇪 Munich, Bavaria, Germany

Clinic of Congenital Heart Disease; 🇩🇪 Berlin, Germany

OPBG Rome; 🇮🇹 Roma, Lazio, Italy

S. Donato Milan; 🇮🇹 Milan, Lombardy, Italy

Leeds General Infirmary; 🇬🇧 Leeds, England, United Kingdom

Evelina Children's Hospital; 🇬🇧 London, England, United Kingdom