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Study of the Native Outflow Tract Transcatheter Pulmonary Valve (TPV)

NCT01762124 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-08-07

No results posted yet for this study

Summary

The purpose of this early feasibility study is to determine how a new transcatheter pulmonary valve will move and perform once implanted in the right ventricular outflow tract.

Conditions

  • Congenital Heart Disease
  • Tetralogy of Fallot

Interventions

DEVICE

Native Outflow Tract TPV

Transcatheter placement of a pulmonary valve

Sponsors & Collaborators

  • Medtronic Heart Valves

    lead INDUSTRY

Principal Investigators

  • Lee Benson, MD · The Hospital for Sick Children, Toronto, Canada

  • John P. Cheatham, MD · Nationwide Children's Hospital, Columbus, Ohio, USA

  • Lisa Bergersen, MD, MPH · Boston Children's Hospital, Boston, Massachusetts, USA

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-05-31
Completion
2020-07-31
FDA Device
Yes

Countries

  • United States
  • Canada

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 NCT01762124 on ClinicalTrials.gov