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Clinical Trial 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.


Clinical Trial Description

Medtronic, Inc. is in the process of developing a novel transcatheter device option for patients with congenital heart disease, without right ventricle-to-pulmonary artery conduits, called the Native Outflow Tract Transcatheter Pulmonary Valve. Given limitations in the animal model to confirm device boundary conditions, this feasibility study is proposed to characterize that information as well as evaluate safety, procedural feasibility and performance data to be used for future development of the device. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01762124
Study type Interventional
Source Medtronic Cardiovascular
Contact
Status Completed
Phase N/A
Start date October 2012
Completion date July 2020

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