Aortic Valve StenosisNCT01636648
Enable I Long-term Follow-up Study
An observational study of Aortic Valve Stenosis and Aortic Valve Insufficiency, run by Medtronic Cardiac Rhythm and Heart Failure at 6 sites in 3 countries.
Trial summary
This was a prospective, non-randomized, multi-center, non-interventional post-market study. The study was a post-market long-term follow-up study based on the same cohort of patients (148 patients) enrolled in a previous investigational study from March 2007 to December 2009 (ATS 3f Enable™ Aortic Bioprosthesis Model… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- What is being tested?
- Aortic Valve Replacement
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Aug 2012to Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were enrolled and implanted during the previous investigational study named "ATS 3f Enable™ Aortic Bioprosthesis Model 6000" (study number S2005).
Who may be able to join
- Patients who were enrolled and implanted for the ATS 3f Enable™ Aortic Bioprosthesis Model 6000, number S2005
- Patient willing to sign the new Data Release form (DRF) or Patient Informed Consent (PIC) for the post-market study (what is applicable for the study due to local requirements and regulations)
Who cannot join
- ATS 3f Enable™ Aortic Bioprosthesis Model 6000 was explanted
- Patient died
- Patient lost to follow-up
- Patient withdrew consent
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany3 sites
Johann Wolfgang Goethe University
Frankfurt, D-60590
University Medical Center Freiburg
Freiburg im Breisgau, 79106
University Medical Center Kiel
Kiel, 24105
Switzerland2 sites
Universitätsspital Basel
Basel, CH-4031
Inselspital Bern
Bern, CH-3010
About this study
This was a prospective, non-randomized, multi-center, non-interventional post-market study. The study was a post-market long-term follow-up study based on the same cohort of patients (148 patients) enrolled in a previous investigational study from March 2007 to December 2009 (ATS 3f Enable™ Aortic Bioprosthesis Model 6000, number S2005) involving 10 European sites. Patient follow-up took place on a yearly basis up to 10 years after the implant/enrollment. The primary objective of this study was to evaluate the safety and effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis during long-term follow-up.
As this was an observational study, safety and efficacy data were summarized and described. There was no statistically powered study hypothesis.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- Being tested
- Aortic Valve Replacement
- Keywords
- Aortic Valve Replacement, Aortic Valve Bioprosthesis
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic Valve ReplacementDevice
Aortic Valve Replacement with Medtronic ATS 3f ENABLE® Aortic Bioprosthesis Model 6000
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the Long-term safety of the Medtronic ATS Enable Aortic Bioprosthesis
Long-term safety will be assessed by collecting following reported adverse events addressed: Migration, Valve Related Thromboembolism, Valvular thrombosis, Haemorrhage, Perivalvular Leak, Endocarditis, Hmolysis, Structural valve Deterioration, Non-Structural Dysfunction, Reoperation, Explant and Death.
Measured: 10 Years Post-Procedure
Assess the Long-term Clinical Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: NYHA Functional Classification
Long-term clinical effectiveness of the Aortic Bioprosthesis will be assessed by collecting the NYHA-class of enrolled subjects over a period of time, following surgery.
Measured: 10 Years Post-Procedure
Long-term Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: Hemodynamic Performance
Hemodynamic performance of the Aortic Bioprosthesis will be assessed by specific echocardiography measurements
Measured: 10 Years Post-Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Device was sunset from the market in May2015. No longer need for long term data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thierry Carrel, Prof., Principal investigator, Inselspital Bern, Klinik für Herz-und Gefasschirurgie, CH-3010 Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636648
- Sponsor's protocol ID
- En_2012
- Status last verified
- Nov 2017
- First submitted
- 6 Jul 2012
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Martens S, Sadowski J, Eckstein FS, Bartus K, Kapelak B, Sievers HH, Schlensak C, Carrel T. Clinical experience with the ATS 3f Enable(R) Sutureless Bioprosthesis. Eur J Cardiothorac Surg. 2011 Sep;40(3):749-55. doi: 10.1016/j.ejcts.2010.12.068. Epub 2011 Feb 20.
PubMed 21342776Englberger L, Carrel TP, Doss M, Sadowski J, Bartus K, Eckstein FF, Asch FM, Martens S. Clinical performance of a sutureless aortic bioprosthesis: five-year results of the 3f Enable long-term follow-up study. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1681-7. doi: 10.1016/j.jtcvs.2014.03.054. Epub 2014 Apr 4.
PubMed 24787699
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enable I Long-term Follow-up Study
- ClinicalTrials.gov ID
- NCT01636648
- Acronym / sponsor ID
- En_2012
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- Keywords
- Aortic Valve Replacement, Aortic Valve Bioprosthesis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Device was sunset from the market in May2015. No longer need for long term data.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Jul 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.
This was a prospective, non-randomized, multi-center, non-interventional post-market study. The study was a post-market long-term follow-up study based on the same cohort of patients (148 patients) enrolled in a previous investigational study from March 2007 to December 2009 (ATS 3f Enable™ Aortic Bioprosthesis Model 6000, number S2005) involving 10 European sites. Patient follow-up took place on a yearly basis up to 10 years after the implant/enrollment. The primary objective of this study was to evaluate the safety and effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis during long-term follow-up.
As this was an observational study, safety and efficacy data were summarized and described. There was no statistically powered study hypothesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were enrolled and implanted during the previous investigational study named "ATS 3f Enable™ Aortic Bioprosthesis Model 6000" (study number S2005).
Key inclusion criteria (2 listed)
- Patients who were enrolled and implanted for the ATS 3f Enable™ Aortic Bioprosthesis Model 6000, number S2005
- Patient willing to sign the new Data Release form (DRF) or Patient Informed Consent (PIC) for the post-market study (what is applicable for the study due to local requirements and regulations)
Key exclusion criteria (4 listed)
- ATS 3f Enable™ Aortic Bioprosthesis Model 6000 was explanted
- Patient died
- Patient lost to follow-up
- Patient withdrew consent
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 |
|---|---|---|
| Aortic Valve ReplacementAortic Valve Replacement with Medtronic ATS 3f ENABLE® Aortic Bioprosthesis Model 6000 | Device | – |
Primary outcome
Assess the Long-term safety of the Medtronic ATS Enable Aortic Bioprosthesis
Time frame: 10 Years Post-Procedure
Long-term safety will be assessed by collecting following reported adverse events addressed: Migration, Valve Related Thromboembolism, Valvular thrombosis, Haemorrhage, Perivalvular Leak, Endocarditis, Hmolysis, Structural valve Deterioration, Non-Structural Dysfunction, Reoperation, Explant and Death.
Assess the Long-term Clinical Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: NYHA Functional Classification
Time frame: 10 Years Post-Procedure
Long-term clinical effectiveness of the Aortic Bioprosthesis will be assessed by collecting the NYHA-class of enrolled subjects over a period of time, following surgery.
Long-term Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: Hemodynamic Performance
Time frame: 10 Years Post-Procedure
Hemodynamic performance of the Aortic Bioprosthesis will be assessed by specific echocardiography measurements
Results and safety
The study was stopped early (reason given: Device was sunset from the market in May2015. No longer need for long term data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Background: PubMed 21342776Martens S, Sadowski J, Eckstein FS, Bartus K, Kapelak B, Sievers HH, Schlensak C, Carrel T. Clinical experience with the ATS 3f Enable(R) Sutureless Bioprosthesis. Eur J Cardiothorac Surg. 2011 Sep;40(3):749-55. doi: 10.1016/j.ejcts.2010.12.068. Epub 2011 Feb 20.
- Background: PubMed 24787699Englberger L, Carrel TP, Doss M, Sadowski J, Bartus K, Eckstein FF, Asch FM, Martens S. Clinical performance of a sutureless aortic bioprosthesis: five-year results of the 3f Enable long-term follow-up study. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1681-7. doi: 10.1016/j.jtcvs.2014.03.054. Epub 2014 Apr 4.
- Individual participant dataSharing planned: No
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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.
Thierry Carrel, Prof. principal investigator
Inselspital Bern, Klinik für Herz-und Gefasschirurgie, CH-3010 Bern
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Aortic Valve Insufficiency, run by Medtronic Cardiac Rhythm and Heart Failure at 6 sites in 3 countries.
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 4 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 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Switzerland, Poland. 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: Device was sunset from the market in May2015. No longer need for long term data.). 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?
Assess the Long-term safety of the Medtronic ATS Enable Aortic Bioprosthesis (time frame: 10 Years Post-Procedure). 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 NCT01636648, which also lists 2 linked publications.
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 21 Nov 2017.