Post-Approval Study for the MOSAIC® Bioprostheses
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.
Aortic Valve Stenosis and/or Insufficiency
Mitral Valve Stenosis and/or Insufficiency
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Post-Approval Study for the MOSAIC® Bioprostheses: A Long Term Follow Up Study.|
- 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)
|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)|
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.
The primary objectives of this study are to evaluate the long-term safety, efficacy and clinical performance.
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.
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574625
|Hamburg, Germany, 22457|
|Principal Investigator:||Friedrich Christian Rieß, Prof. Dr.||Albertinen-Krankenhaus Hamburg|