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

This study has been withdrawn prior to enrollment.
(Study terminated prematurely.)
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01156272
First received: June 28, 2010
Last updated: July 1, 2013
Last verified: July 2013

June 28, 2010
July 1, 2013
June 2010
Not Provided
  • New York Heart Association (NYHA) Functional Classification [ Time Frame: <30 days / discharge, whichever comes last, 3-6 months, 11-14 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Blood data will be analyzed preoperatively and postopertively 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.
  • Adverse/complication rates [ Time Frame: <30 days / discharge, whichever comes last, 3-6 months, 11-14 months ] [ Designated as safety issue: Yes ]
    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.
Same as current
Complete list of historical versions of study NCT01156272 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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.

Heart Valve Diseases
Device: ATS Medical 3f® Aortic Bioprosthesis, Model 1000 19mm
Replacement aortic heart valve
Other Name: Model 1000, 19mm
Replacement aortic heart valve
ATS 3f® Aortic Bioprosthesis, Model 1000, Size 19mm
Intervention: Device: ATS Medical 3f® Aortic Bioprosthesis, Model 1000 19mm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2011
Not Provided

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01156272
2009
No
Medtronic Cardiovascular
Medtronic Cardiovascular
Not Provided
Study Director: Mike Boulware, PhD Medtronic
Medtronic Cardiovascular
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP