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Observational Study of Venus P-Valve

NCT05835349 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-01-24

No results posted yet for this 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).

Conditions

  • Right Ventricular Outflow Tract Dysfunction

Interventions

DEVICE

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.

Sponsors & Collaborators

  • IQVIA MedTech BV of Antwerp, Belgium

    collaborator UNKNOWN

  • MDCECRO LLC

    collaborator NETWORK

  • Venus MedTech (HangZhou) Inc.

    lead INDUSTRY

Principal Investigators

  • Shakeel A. Qureshi, MD · Evelina Children's Hospital

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-26
Primary Completion
2026-08-31
Completion
2032-12-31

Countries

  • France
  • Germany
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05835349 on ClinicalTrials.gov