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

Withdrawn

• Conditions: Heart Valve Diseases
• Interventions: Device: ATS Medical 3f® Aortic Bioprosthesis, Model 1000 19mm

• Registration Number: NCT01156272
• Lead Sponsor: Medtronic Cardiovascular

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-02
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-04
• Last Update Posted: 2015-08-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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-2009. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Replacement aortic heart valve	ATS Medical 3f® Aortic Bioprosthesis, Model 1000 19mm	ATS 3f® Aortic Bioprosthesis, Model 1000, Size 19mm

Primary Outcome Measures

Name	Time	Method
Adverse/complication rates	<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	<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	<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.

Trial Locations

Locations (1)

McGill University Health Centre, Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada