Post-Approval Study for the MOSAIC® Bioprostheses

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis and/or Insufficiency; Mitral Valve Stenosis and/or Insufficiency

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.

• Study Type: Observational
• Enrollment (Actual): 177

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 22457
    • Albertinen Krankenhaus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medtronic Bakken Research Center
• Investigators: Principal Investigator: Friedrich Christian Rieß, Prof. Dr., Albertinen-Krankenhaus Hamburg

Publications and helpful links

General Publications

• 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.

Helpful Links

• General Medtronic website

Study record dates

Study Major Dates

• Study Start: April 1, 2001
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: April 6, 2012
• First Submitted That Met QC Criteria: April 6, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Actual): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic; Mitral Valve Stenosis
• Other Study ID Numbers: Mosaic (ArQule)