Heart Valve StenosisNCT01264484
ADVANTAGE® Prosthetic Heart Valve Long-term Follow-up Trial
An observational study of Heart Valve Stenosis, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in Germany.
Trial summary
The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Valve Stenosis
- What is being tested?
- Advantage Prosthetic Heart Valve
- Type of treatment
- Medical device
- How many people
- 212 participants
- Where
- 2 sitesGermany
- Study dates
- Dec 2010to Mar 2016
- 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 already enrolled in the ADVANTAGE Prosthetic Heart Valve Study in two German Centers and are still available for follow-up
Who may be able to join
- 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
Who cannot join
- High probability of non-adherence to physician's follow-up requirements
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Herz- und Diabetescentrum Bad Oeynhausen
Bad Oeynhausen, 32545
Deutsches Herzzentrum Munchen
München, 80636
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Valve Stenosis
- Being tested
- Advantage Prosthetic Heart Valve
- Keywords
- Advantage, Non-interventional, Post market release study, Germany, Treated with Advantage prosthetic heart valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advantage Prosthetic Heart ValveDevice
All patients eligible for this study are treated with an Advantage prosthetic heart valve
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Advantage Prosthetic Heart Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety and durability of the valve
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
Measured: 5 year follw-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2015
- Study completionMar 2016
Why it stopped: The primary objective was considered sufficient for follow-up.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve StenosisStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rudiger Lange, Prof. Dr., Principal investigator, Deutsches Herzzentrum MünchenJan Gummert, prof. dr., Principal investigator, Herzzentrum Nordrhein-Westfalen, Bad Oeynhausen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264484
- Sponsor's protocol ID
- ADVANTAGE
- Status last verified
- Mar 2017
- First submitted
- 20 Dec 2010
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADVANTAGE Prosthetic Heart Valve Long Term Follow Up
- ClinicalTrials.gov ID
- NCT01264484
- Acronym / sponsor ID
- ADVANTAGE
- Conditions
- Heart Valve Stenosis
- Keywords
- Advantage, Non-interventional, Post market release study, Germany, Treated with Advantage prosthetic heart valve
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The primary objective was considered sufficient for follow-up.
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 Dec 2010 (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.
The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advantage prosthetic heart valve | – | Device: Advantage Prosthetic Heart ValveAll 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. |
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 already enrolled in the ADVANTAGE Prosthetic Heart Valve Study in two German Centers and are still available for follow-up
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- High probability of non-adherence to physician's follow-up requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advantage Prosthetic Heart ValveAll patients eligible for this study are treated with an Advantage prosthetic heart valve | Device | Advantage prosthetic heart valve |
Primary outcome
Long-term safety and durability of the valve
Time frame: 5 year follw-up
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
Results and safety
The study was stopped early (reason given: The primary objective was considered sufficient for follow-up.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- general Medtronic websiteLink provided by the sponsor.
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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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.
Rudiger Lange, Prof. Dr. principal investigator
Deutsches Herzzentrum München
Jan Gummert, prof. dr. principal investigator
Herzzentrum Nordrhein-Westfalen, Bad Oeynhausen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Stenosis, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: The primary objective was considered sufficient for follow-up.). Results are not available in the source record.
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 and durability of the valve (time frame: 5 year follw-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2017.