Observational Study of Venus P-Valve

Last updated: January 21, 2025
Sponsor: Venus MedTech (HangZhou) Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

transcatheter pulmonary valve implantation (TPVI)

Clinical Study ID

NCT05835349
VTPR-22-08
  • Ages 12-70
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria

  1. Patients with native RVOT (including transvalvular patch repair) are present withmoderate or greater pulmonary regurgitation with/without stenosis and are clinicallyindicated for pulmonary valve intervention.

  2. The patient (or the patient's legally authorized representative) is willing toconsent to participate in the study and will commit to completing all follow-uprequirements.

Exclusion

Exclusion Criteria:

  1. Patients with any condition contraindicated by the IFU or inability to comply withthe Venus P-ValveTM System Instructions for Use or the study protocol.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: transcatheter pulmonary valve implantation (TPVI)
Phase:
Study Start date:
August 26, 2024
Estimated Completion Date:
December 31, 2032

Study 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.

Connect with a study center

  • Marie Lannelongue

    le Plessis Robinson, Hauts-de-Seine 92350
    France

    Site Not Available

  • CHU Bordeaux

    Pessac, Nouvelle-Aquitaine 33600
    France

    Site Not Available

  • Chu Nantes

    Nantes, Pays de la Loire 44093
    France

    Active - Recruiting

  • Marie Lannelongue

    Le Plessis-Robinson, Île-de-France 92350
    France

    Active - Recruiting

  • Hopital Necker-Enfants malades

    Paris, Île-de-France 75015
    France

    Active - Recruiting

  • Heart CenterMunich

    Munich, Bavaria 81377
    Germany

    Site Not Available

  • Clinic of Congenital Heart Disease

    Berlin, 13353
    Germany

    Site Not Available

  • OPBG Rome

    Roma, Lazio 165
    Italy

    Site Not Available

  • S. Donato Milan

    Milan, Lombardy 20097
    Italy

    Site Not Available

  • Leeds General Infirmary

    Leeds, England LS1 3EX
    United Kingdom

    Site Not Available

  • Evelina Children's Hospital

    London, England SE1 7EH
    United Kingdom

    Site Not Available

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