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Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts

NCT02846753 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-04-21

No results posted yet for this study

Summary

A prospective, non-randomized multi-center clinical investigation of the Venus P-Valve™ for the treatment of pulmonary regurgitation with or without stenosis in patient with native outflow tracts.

Conditions

  • Pulmonary Regurgitation

Interventions

PROCEDURE

trans catheter heart valve replacement

trans catheter heart valve replacement

Sponsors & Collaborators

  • IQVIA Inc.

    collaborator INDUSTRY

  • TheraGenesis

    collaborator UNKNOWN

  • Intrials

    collaborator UNKNOWN

  • Venus MedTech (HangZhou) Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-08-17
Primary Completion
2022-07-31
Completion
2024-12-31

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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 NCT02846753 on ClinicalTrials.gov