Observational Study of Venus P-Valve (Registry)

January 21, 2025 updated by: Venus MedTech (HangZhou) Inc.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Nouvelle-Aquitaine
      • Pessac, Nouvelle-Aquitaine, France, 33600
    • Pays de la Loire
      • Nantes, Pays de la Loire, France, 44093
    • Île-de-France
      • Le Plessis-Robinson, Île-de-France, France, 92350
        • Recruiting
        • Marie Lannelongue
        • Contact:
      • Paris, Île-de-France, France, 75015
        • Recruiting
        • Hôpital Necker-Enfants Malades
        • Contact:
  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Not yet recruiting
        • Heart CenterMunich
        • Contact:
  • Italy
  • United Kingdom
    • England
      • Leeds, England, United Kingdom, LS1 3EX
      • London, England, United Kingdom, SE1 7EH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Baseline enrolment criteria

  • 12 years old up to 70 years old
  • Weight ≥ 30kg
  • With evidence of moderate or severe (≥3+) pulmonary regurgitation by Transthoracic Echocardiography (TTE)
  • With >30% pulmonary regurgitation fraction as defined by cardiac Magnetic Resonance Imaging (MRI)
  • The subject is symptomatic from his/her pulmonary regurgitation or meets MRI criteria for intervention Right Ventricular Ejection Fraction (RVEF) < 45%, Pulmonary Regurgitant Fraction (PRRF) >30% and increased Right Ventricular End Diastolic Volume (RVEDV) Index (RVEDVI) >150mL/m²

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-hierarchical composite endpoint
Time Frame: 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.
at six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 30 days
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
through five years
Functional status
Time Frame: through five years
New York Heart Association (NYHA) classification out to 5 years
through five 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.
through five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Venus MedTech (HangZhou) Inc.

Collaborators

IQVIA MedTech BV of Antwerp, Belgium
MDCECRO LLC

Investigators

  • Principal Investigator: Shakeel A. Qureshi, MD, Evelina Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2032

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • VTPR-22-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Under attention to laws and regulations concerning personal data protection, empirical (non personally identifiable) data is anticipated to be shared within the clinical investigator team. Processed and analysed data would be shared within a wider community of medical professionals through professional conference presentations and peer-reviewed journal publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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