Aortic Valve Stenosis and/or InsufficiencyNCT01574625
Post-Approval Study for the MOSAIC® Bioprostheses
An observational study of Aortic Valve Stenosis and/or Insufficiency and Mitral Valve Stenosis and/or Insufficiency, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis and/or Insufficiency, Mitral Valve Stenosis and/or Insufficiency
- How many people
- 177 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2001to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
long-term safety of the valve
The long-term safety of the valve will be assessed by the rate of valve related complications.
Measured: 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
Measured: 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)
Measured: Long term follow up: 10 years and longer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startApr 2001
- Primary completionFeb 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve Stenosis and/or InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Friedrich Christian Rieß, Prof. Dr., Principal investigator, Albertinen Krankenhaus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574625
- Sponsor's protocol ID
- MOSAIC
- Status last verified
- Feb 2019
- First submitted
- 6 Apr 2012
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19695889
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Approval Study for the MOSAIC® Bioprostheses: A Long Term Follow Up Study.
- ClinicalTrials.gov ID
- NCT01574625
- Acronym / sponsor ID
- MOSAIC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Primary completion
- Feb 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Results publication: PubMed 19695889Riess 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.
- General Medtronic websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Friedrich Christian Rieß, Prof. Dr. principal investigator
Albertinen Krankenhaus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and/or Insufficiency and Mitral Valve Stenosis and/or Insufficiency, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
long-term safety of the valve (time frame: Long term follow up: 10 years and longer). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01574625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.