Post-Approval Study for the MOSAIC® Bioprostheses

NCT01574625 | Completed

• 1 other identifier: MOSAIC
• Study Type: observational
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis and/or Insufficiency; Mitral Valve Stenosis and/or Insufficiency

Outcome Measures

Primary Outcomes (3)

• long-term safety of the valve

  The long-term safety of the valve will be assessed by the rate of valve related complications.

  Long term follow up: 10 years and longer

• The long-term durability of the valve will be assessed by measuring hemodynamic performance of the valve Long-term performance of the valve

  The long-term performance of the valve will be assessed by measuring hemodynamic performance of the valve by echo

  Long term follow up: 10 years and longer

• Long-term efficacy of the valve

  The long-term efficacy of the valve will be assessed by evaluating the New York Heart Association Functional Classification (NYHA)

  Long term follow up: 10 years and longer

Study Arms (1)

Mosaic prosthetic heart valve

All patients who were enrolled and implanted with a Mosaic bioprosthesis in the Albertinen-Krankenhaus (Hamburg, Germany) during the previous Mosaic PMA study and who agree to participate in this long-term follow-up study by informed consent.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subject population for this study includes all patients who were enrolled and implanted with a Mosaic bioprosthesis in the Albertinen-Krankenhaus (Hamburg, Germany) during the previous Mosaic PMA study and who are still available for follow-up.

You may qualify if:

• All patients who were enrolled and implanted with a 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

You may not qualify if:

• Patients who are not from the Albertinen-Krankenhaus (Hamburg, Germany) and who did not participate in the Mosaic PMA study are ineligible for this study.
• Patients refusing or not able to provide informed consent.
• Patients not willing and unable to comply with the CIP-requirements

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (1)

Albertinen Krankenhaus

Hamburg, 22457, Germany

Location

Related Publications (1)

• Riess FC, Cramer E, Hansen L, Schiffelers S, Wahl G, Wallrath J, Winkel S, Kremer P. Clinical results of the Medtronic Mosaic porcine bioprosthesis up to 13 years. Eur J Cardiothorac Surg. 2010 Jan;37(1):145-53. doi: 10.1016/j.ejcts.2009.04.073. Epub 2009 Aug 19.

  PMID: 19695889 RESULT

Related Links

• General Medtronic website

Study Officials

• Friedrich Christian Rieß, Prof. Dr.

  Albertinen Krankenhaus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2012
• First Posted: April 10, 2012
• Study Start: April 1, 2001
• Primary Completion: February 1, 2018
• Study Completion: June 1, 2018
• Last Updated: May 1, 2019

Record last verified: 2019-02

Locations

DE (1)