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

3f 19mm IDE Study Rev D

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.

Study Overview

• Status: Withdrawn
• Conditions: Heart Valve Diseases
• Intervention / Treatment: Device: ATS Medical 3f® Aortic Bioprosthesis, Model 1000 19mm

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 Type: Observational

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • McGill University Health Centre, Royal Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who were previously implanted with the ATS 3f Aortic Bioprosthesis Model 1000 (size 19mm) between the dates 1-Jan-2009 and 31-Dec-2009 and who meet the eligibility criteria.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Replacement aortic heart valve; ATS 3f® Aortic Bioprosthesis, Model 1000, Size 19mm	Device: ATS Medical 3f® Aortic Bioprosthesis, Model 1000 19mm; Replacement aortic heart valve; Other Names: Model 1000, 19mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	<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.	<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.	<30 days / discharge, whichever comes last, 3-6 months, 11-14 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Investigators: Study Director: Mike Boulware, PhD, Medtronic

Publications and helpful links

Helpful Links

• Corporate Website

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 28, 2010
• First Submitted That Met QC Criteria: July 1, 2010
• First Posted (Estimate): July 2, 2010

Study Record Updates

• Last Update Posted (Estimate): August 6, 2015
• Last Update Submitted That Met QC Criteria: August 4, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: heart valve; Isolated aortic valve replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases
• Other Study ID Numbers: 2009