Post Market ATS 3f® Aortic Bioprosthesis, Model 1000, Size 19mm

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of the ATS 3f® Aortic Bioprosthesis, Model 1000 (Equine Pericardial Bioprothesis) size 19mm in a patient population undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.

Clinical Trial Description

A multi-center, post market, non-randomized trial, designed to obtain safety and efficacy data from patients implanted with the size 19mm Model 1000 heart valve. Each enrolled patient will be followed until one year post-implantation. Data will be collected both retrospectively and prospectively, on patients who were implanted from 1-Jan-2009 to 31-Dec-2009 with the 19mm Model 1000. The data collected will be pooled with the data currently collected, under the U.S. Food and Drug Administration (FDA) IDE Number G01284 for submission to the U.S. FDA. ;

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Heart Valve Diseases

Clinical Trial Details

NCT number	NCT01156272
Study type	Observational
Source	Medtronic Cardiovascular
Contact
Status	Withdrawn
Phase	N/A
Start date	June 2010
Completion date	June 2011

View Details

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