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Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation

NCT02071654 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2015-01-06

No results posted yet for this study

Summary

A prospective, non-randomized, multi-center clinical study of the Venus P-valve for the treatment of RVOT stenosis with pulmonary regurgitation after surgery of congenital heart defect.

Conditions

  • Right Ventricular Outflow Tract Stenosis

Interventions

DEVICE

Venus P-valve transcatheter implantation

Percutaneous implantation of Venus-P valve to treat RVOT stenosis patients

Sponsors & Collaborators

  • Core Medical (Beijing) Co., Ltd.

    collaborator OTHER

  • Venus MedTech (HangZhou) Inc.

    lead INDUSTRY

Principal Investigators

  • Junbo Ge, Prof., MD. · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-02-28
Completion
2016-02-29

Countries

  • China

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 NCT02071654 on ClinicalTrials.gov