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Post-Approval Study for the MOSAIC® Bioprostheses

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01574625
First Posted: April 10, 2012
Last Update Posted: April 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
  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 Cardiovascular ( Medtronic Bakken Research Center ):

Primary Outcome Measures:
  • long-term safety of the valve [ Time Frame: Long term follow up: 10 years and longer ]
    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 ]
    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 ]
    The long-term efficacy of the valve will be assessed by evaluating the New York Heart Association Functional Classification (NYHA)


Enrollment: 178
Study Start Date: April 2001
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: April 6, 2012
First Posted: April 10, 2012
Last Update Posted: April 18, 2017
Last Verified: April 2017

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