Post-Approval Study for the MOSAIC® Bioprostheses

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Aortic Valve Stenosis and/or Insufficiency, Mitral Valve Stenosis and/or Insufficiency

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mosaic prosthetic heart valve<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |