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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention
Heart Valve Diseases
Device: ATS Medical 3f® Aortic Bioprosthesis, Model 1000 19mm

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 3f 19mm IDE Study Rev D

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • 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.


Enrollment: 0
Study Start Date: June 2010
Study Completion Date: June 2011
Groups/Cohorts Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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-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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156272

Locations
Canada, Quebec
McGill University Health Centre, Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
Study Director: Mike Boulware, PhD Medtronic
  More Information

Additional Information:
No publications provided

Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT01156272     History of Changes
Other Study ID Numbers: 2009
Study First Received: June 28, 2010
Last Updated: July 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Cardiovascular:
Isolated aortic valve replacement
heart valve

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014