Post-Approval Study for the MOSAIC® Bioprostheses

Aortic Valve Stenosis and/or Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574625
• Other study ID #: MOSAIC
• Status: Completed
• Start date: April 2001
• Est. completion date: June 2018

Study information

• Verified date: February 2019
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: June 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Aortic Valve Stenosis and/or Insufficiency
• Constriction, Pathologic
• Mitral Valve Stenosis
• Mitral Valve Stenosis and/or Insufficiency

Locations

Country	Name	City	State
Germany	Albertinen Krankenhaus	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

Germany, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   General Medtronic website