Recruiting

NCT Number: NCT05835349

Observational Study of Venus P-Valve

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).

Recruiting

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Key information

Conditions

Right Ventricular Outflow Tract Dysfunction

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Bordeaux, Pessac, New Aquitaine, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
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

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.

Treatment and study plan

transcatheter pulmonary valve implantation (TPVI)

Device

A stent-mounted valve is introduced over a guidewire and positioned in the RVOT, followed by balloon inflation to deploy the valve.

Primary outcomes

Non-hierarchical composite endpoint

Time frame: at six months
- Freedom from VenusP-ValveTM (catheter or surgical) reintervention
- Acceptable hemodynamic function, defined as:
- Mild or less regurgitation measured by echocardiography; AND
- Mean RVOT gradient as measured by echocardiography ≤35mmHg.

Secondary outcomes

Procedural Success

Time frame: 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

Time frame: 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

Time frame: through five years

New York Heart Association (NYHA) classification out to 5 years
Health-state utility score

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cong Ma

CONTACT

[email protected]

+86 18817939751

Ping Zhang

CONTACT

[email protected]

15802168031

Sponsors and collaborators

Lead sponsor

Venus MedTech (HangZhou) Inc.

Industry

Collaborators

IQVIA MedTech BV of Antwerp, Belgium
MDCECRO LLC

Registry information

Official study title

A Real-World Evidence Observational Study of VenusP-ValveTM System in the Treatment of Patients with Native RVOT Dysfunction

Acronym: Registry

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2032
First posted: Apr 28, 2023
Registry last updated: Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.