Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

Status Completed

Clinical Trial Summary

The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.

Clinical Trial Description

This is a prospective, non-randomized, non-controlled observational clinical trial. Up to 200 subjects will be enrolled at up to 6 participating clinical sites. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic valve. Patients will be followed and assessed after implant for up to 5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01651052
Study type	Interventional
Source	Edwards Lifesciences
Contact
Status	Completed
Phase	N/A
Start date	July 2011
Completion date	July 2018

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