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Clinical Trial Summary

The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic aortic or mitral valve.


Clinical Trial Description

Multicenter, prospective, single arm trial - Up to seven hundred (700) aortic valve replacement (AVR) subjects and up to one hundred seventy-five (175) mitral valve replacement (MVR) subjects at up to forty (40) clinical sites will be enrolled. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valve. Patients will be followed and assessed after implant for up to 5 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01757665
Study type Interventional
Source Edwards Lifesciences
Contact
Status Active, not recruiting
Phase N/A
Start date December 11, 2012
Completion date August 2026

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