Clinical Trial: Post-Approval Study for the MOSAIC® Bioprostheses

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Post-Approval Study for the MOSAIC® Bioprostheses: A Long Term Follow Up Study.

Brief Summary: A Single Center Non-Interventional Post-Market Release, Long Term Follow Up study of patients who underwent Isolated Aortic Valve Replacement or Isolated Mitral Valve Replacement with a Medtronic Mosaic Bioprosthesis. The purpose of this study is to evaluate the long term safety, efficacy and clinical performance of the Mosaic Bioprostheses.

Detailed Summary:

Objectives:

The primary objectives of this study are to evaluate the long-term safety, efficacy and clinical performance.

Study Design:

This is a prospective, single center, non-interventional, non-randomized, post-market release clinical study

Sample Size and Study Duration:

A total of 255 patients had aortic valve replacement and 47 patients had mitral valve replacement in the Albertinen-Krankenhaus (Hamburg, Germany) during the previous Mosaic Pre-Market approval (PMA) study.

All surviving patients from the Mosaic Pre-Market Approval study at this center, will be invited to participate. Approximately 225 patients will be invited.

This study is intended to serve as an ongoing source of information on long-term durability and safety of the CE-marked Medtronic Mosaic bioprosthesis. As such the study is to continue indefinitely until the last follow-up visit (until patient study exit due to patient death, withdrawal of patient consent,...) of the last study patient.

PATIENT SELECTION:

Inclusion criteria:

  • All patients who were enrolled and implanted with the Mosaic bioprosthesis in the Albertinen-Krankenhaus (Hamburg, Germany) during the previous Mosaic PMA study, will be invited to participate in this long- term follow-up study.
  • Patients who are able to provide informed consent

Exclusion criteria:

    Sponsor: Medtronic Bakken Research Center

    Current Primary Outcome:

    • long-term safety of the valve [ Time Frame: Long term follow up: 10 years and longer ]
      The long-term safety of the valve will be assessed by the rate of valve related complications.
    • The long-term durability of the valve will be assessed by measuring hemodynamic performance of the valve Long-term performance of the valve [ Time Frame: Long term follow up: 10 years and longer ]
      The long-term performance of the valve will be assessed by measuring hemodynamic performance of the valve by echo
    • Long-term efficacy of the valve [ Time Frame: Long term follow up: 10 years and longer ]
      The long-term efficacy of the valve will be assessed by evaluating the New York Heart Association Functional Classification (NYHA)


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Medtronic Cardiovascular

    Dates:
    Date Received: April 6, 2012
    Date Started: April 2001
    Date Completion: January 2018
    Last Updated: April 17, 2017
    Last Verified: April 2017