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Multi-center Trial of Percutaneous Pulmonary Valve Implantation With Venus-p

NCT02590679 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2015-10-29

No results posted yet for this study

Summary

Venus-P Valve (Venus Medtech, Shanghai, China) is the first self-expandable interventional Pulmonary Valve, which is composed of a Nitinol multilevel support frame with a tri-leaflet porcine pericardial tissue valve, and a 14-22 Fr delivery catheter. The purpose of the multi-center trial is to evaluate the safety and efficacy of the Venus-P Valve for percutaneous pulmonary valve implantation (PPVI) in patients pulmonary regurgitation and native right ventricular outflow tract (RVOT) after surgical repair of RVOT.

Conditions

  • Pulmonary Regurgitation
  • Tetralogy of Fallot

Interventions

DEVICE

Venues-P Valve

a Novel Self-Expanding Percutaneous Stent-Valve in the Native Right Ventricular Outflow Tract

Sponsors & Collaborators

  • Fu Wai Hospital, Beijing, China

    collaborator OTHER

  • Huaxi Hospital

    collaborator OTHER

  • Shanghai Chest Hospital

    collaborator OTHER

  • Shanghai Children's Medical Center

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Junbo Ge, M.D. · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-07-31
Completion
2017-02-28

Countries

  • China

Study Locations

More Related Trials

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 NCT02590679 on ClinicalTrials.gov