Post-Approval Study for the MOSAIC® Bioprostheses

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01574625
First received: April 6, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Post-Approval Study for the MOSAIC® Bioprostheses: A Long Term Follow Up Study.

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • long-term safety of the valve [ Time Frame: Long term follow up: 10 years and longer ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The long-term efficacy of the valve will be assessed by evaluating the New York Heart Association Functional Classification (NYHA)


Enrollment: 225
Study Start Date: April 2001
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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:

  • 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 Clinical Investigation Plan (CIP)-requirements.

Data Requirements and analysis:

For each patient enrolled in the study, information will be collected annually. Data will be collected on the patient status and device hemodynamic performance by echocardiography. Patient identity is anonymized.

Appropriate statistical analysis will be performed for the collected clinical data.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  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: NCT01574625

Locations
Germany
Albertinen Krankenhaus
Hamburg, Germany, 22457
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: Friedrich Christian Rieß, Prof. Dr. Albertinen-Krankenhaus Hamburg
  More Information

Additional Information:
Publications:
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01574625     History of Changes
Other Study ID Numbers: MOSAIC
Study First Received: April 6, 2012
Last Updated: April 6, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Mitral Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 20, 2014