3f 19mm IDE Study Rev D
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Valve Diseases
- Sponsor
- Medtronic Cardiovascular
- Locations
- 1
- Primary Endpoint
- Adverse/complication rates
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient required isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve reconstruction with an ATS 3f® Aortic Bioprosthesis Model 1000 (size 19mm) between the dates of 1-Jan-2009 and 31-Dec-
- •The three remaining heart valves must be of native tissue.
- •The patient is geographically stable and willing to return to the implant center for any required follow-up visits.
- •The patient has been adequately informed and consents to his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol.
Exclusion Criteria
- •The patient is twenty (20) or less than twenty years of age.
- •The patient is an intravenous drug and/or alcohol abuser.
- •The patient presented for implant with active endocarditis.
- •The patient presented for implant with congenital bicuspid aortic anatomy.
- •The patient had a previously implanted prosthetic valve that was not replaced by the study valve.
- •The patient required mitral, tricuspid or pulmonic valve replacement.
Outcomes
Primary Outcomes
Adverse/complication rates
Time Frame: <30 days / discharge, whichever comes last, 3-6 months, 11-14 months
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.
New York Heart Association (NYHA) Functional Classification
Time Frame: <30 days / discharge, whichever comes last, 3-6 months, 11-14 months
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.
Blood Data
Time Frame: <30 days / discharge, whichever comes last, 3-6 months, 11-14 months
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.