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.
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 Type
OBSERVATIONAL
Replacement aortic heart valve
McGill University Health Centre, Royal Victoria Hospital
Montreal, Quebec, Canada
New York Heart Association (NYHA) Functional Classification
The NYHA classifications will be analyzed to demonstrate if implanting the of the study valve leads to an improvement in this clinical parameter for the patient.
Time frame: <30 days / discharge, whichever comes last, 3-6 months, 11-14 months
Blood Data
Blood data will be analyzed preoperative and postopertive to demonstrate if implanting of the study valve results in acceptable parameters for Serum Lactate Dehydrogenase (SLDH), Haptoglobin, Hematocrit and Reticulocyte parameters. Platelet and white blood cell count will also be analyzed.
Time frame: <30 days / discharge, whichever comes last, 3-6 months, 11-14 months
Adverse/complication rates
To demonstrate that the adverse/complication rates for the Model 1000 Bioprosthesis are less than two times the Objective Performance Criteria (OPCs) established by the FDA for severe complications.
Time frame: <30 days / discharge, whichever comes last, 3-6 months, 11-14 months
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