ADVANTAGE® Prosthetic Heart Valve Long-term Follow-up Trial
March 29, 2017 updated by: Medtronic Bakken Research Center
ADVANTAGE Prosthetic Heart Valve Long Term Follow Up
The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve in patients who were already implanted with this device.
Study Type
Observational
Enrollment (Actual)
212
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Bad Oeynhausen, Germany, 32545
- Herz- und Diabetescentrum Bad Oeynhausen
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Munchen, Germany, 80636
- Deutsches Herzzentrum München
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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 already enrolled in the ADVANTAGE Prosthetic Heart Valve Study in two German Centers and are still available for follow-up
Description
Inclusion Criteria:
- Participated in the ADVANTAGE Prosthetic Heart Valve Study in Herz- und Diabeteszentrum (Bad Oeynhausen) or Deutsches Herzzentrum (Munich)
- Signed and dated patient data release form
- Available for follow-up
Exclusion Criteria:
- High probability of non-adherence to physician's follow-up requirements
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Advantage prosthetic heart valve
All patients who were enrolled and implanted with an Advantage valve in the Herzzentrum Nordrhein-Westfalen (Bad Oeynhausen, Germany) and Deutsches Herzzentrum München (Munich, Germany) during the previous Advantage clinical study study and who agree to participate in this long-term follow-up study by informed consent.
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All patients eligible for this study are treated with an Advantage prosthetic heart valve
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Long-term safety and durability of the valve
Time Frame: 5 year follw-up
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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
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5 year follw-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jan Gummert, prof. dr., Herzzentrum Nordrhein-Westfalen, Bad Oeynhausen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
December 20, 2010
First Submitted That Met QC Criteria
December 20, 2010
First Posted (Estimate)
December 21, 2010
Study Record Updates
Last Update Posted (Actual)
March 30, 2017
Last Update Submitted That Met QC Criteria
March 29, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADVANTAGE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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