Clinical trial NCT01574625: Post-Approval Study for the MOSAIC® Bioprostheses
Official title: Post-Approval Study for the MOSAIC® Bioprostheses: A Long Term Follow Up Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis and/or Insufficiency
Mitral Valve Stenosis and/or Insufficiency
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 177
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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 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

Primary outcomes:
measure: long-term safety of the valve
timeFrame: Long term follow up: 10 years and longer
measure: The long-term durability of the valve will be assessed by measuring hemodynamic performance of the valve Long-term performance of the valve
timeFrame: Long term follow up: 10 years and longer
measure: Long-term efficacy of the valve
timeFrame: Long term follow up: 10 years and longer
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Albertinen Krankenhaus
Study officials:
affiliation: Albertinen Krankenhaus
name: Friedrich Christian Rieß, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.