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

NCT01156272 | Withdrawn

• 1 other identifier: 2009
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Valve Diseases

Keywords

Isolated aortic valve replacement; heart valve

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Replacement aortic heart valve

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

Device: ATS Medical 3f® Aortic Bioprosthesis, Model 1000 19mm

Interventions

ATS Medical 3f® Aortic Bioprosthesis, Model 1000 19mm DEVICE

Replacement aortic heart valve

Also known as: Model 1000, 19mm

Replacement aortic heart valve

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (1)

McGill University Health Centre, Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Related Links

• Corporate Website

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mike Boulware, PhD

  Medtronic

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: July 2, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 6, 2015

Record last verified: 2015-08

Locations

CA (1)