Aortic Valve StenosisEASENCT01720342
Enable® Aortic Sutureless Bioprosthesis Evaluation
An observational study of Aortic Valve Stenosis and Aortic Valve Insufficiency, run by Medtronic Cardiac Rhythm and Heart Failure at 17 sites in 7 countries.
Trial summary
The EASE Enable study is intended to collect additional data on the clinical outcomes of the Medtronic Enable® Aortic Bioprosthesis in "real world" patients. 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 surgery
- Type of treatment
- Surgery or procedure
- How many people
- 225 participants
- Where
- 17 sitesin 7 countries
- Study dates
- Feb 2013to Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with aortic valve stenosis, aortic valve insufficiency or a combination of the two who require aortic valve replacement are eligible for this study, if they meet all study inclusion criteria and none of the exclusion criteria.
Who may be able to join
- Patient with aortic valve stenosis, aortic valve insufficiency or a combination of the two.
- Patient requires replacement of his/her native aortic valve with a bioprosthesis with or without concomitant procedures.
- Patient is above the minimum age as required by local regulations to be participating in a clinical study.
- Patient is willing to return to the implant site for follow-up visits.
- Patient has been adequately informed of this clinical study and is willing to sign the patient Data Release Form.
Who cannot join
- Patient requires replacement of two or more valves.
- Patient who underwent previous aortic valve replacement (AVR).
- Patient with native bicuspid aortic valve.
- Patient with active endocarditis or other systemic infection.
- Patient dilatation of the ascending aorta, deformations or irregular aortic annulus or ascending aorta geometry as seen via preoperative imaging.
Trial locations and contacts
17 sites in 7 countries.
17 sites in 7 countries
Germany6 sites
Universitätsklinikum Düsseldorf (UKD)
Düsseldorf, 40225
Medizinische Hochschule Hannover (MHH)
Hanover, 30625
Deutssches Herzzentrum Muenchen
Munich, 80636
Universitätsklinikum Münster (UKM)
Münster, 48149
Klinikum Oldenburg GmbH
Oldenburg, 26133
Universitätsklinikum Ulm
Ulm, 89081
Italy3 sites
Casa Di Cura Privata 'Montevergine' S.p.A.
Mercogliano, 83013
Ospedale Luigi Sacco
Milan, 20157
Azienda Complesso Ospedaliero S.Filippo Neri
Rome, 00135
France2 sites
Centre Hospitalier Régional Universitaire de Lille (CHRU)
Lille, 59037
Centre Hospitalier Universitaire de Saint-Etienne Hôpital Nord
Saint-Etienne
Netherlands2 sites
Medisch Centrum Leeuwarden
Leeuwarden, 8934AD
Leids Universitair Medisch Centrum
Leiden, 2300 RC
Spain2 sites
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospiten Rambla
Santa Cruz de Tenerife, 38001
United Kingdom1 site
The James Cook University Hospital
Middlesbrough, TS4 3BW
About this study
Official title: Enable® Aortic Sutureless Bioprosthesis Evaluation: A Post-market Release Non-interventional Study
The EASE Enable study is intended to collect additional data on the clinical outcomes of the Medtronic Enable® Aortic Bioprosthesis in "real world" patients.
Read the detailed description
The EASE Enable study is intended to characterize the clinical performance of the Medtronic Enable® aortic bioprosthesis in a post-market real-world setting.
This is a Non-randomized, prospective, non-interventional multi-center post-market release (PMR) study. Up to 800 subjects will be enrolled at up to 40 centers in Europe. After aortic valve replacement with the Enable® aortic bioprosthesis, each patient will have routine follow-up visits at the following intervals: at 30 days post-implant (at 30 days post-implant or prior to hospital discharge, whatever comes first), within 6 months following implantation, 1 year and annually thereafter up to 5 years post-implant.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- Being tested
- Aortic Valve Replacement surgery
- Keywords
- Medtronic Enable® aortic bioprosthesis, Aortic valve stenosis, Aortic valve insufficiency, "Real world" patients
- 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 Replacement surgeryProcedure or surgery
Also called Medtronic ATS 3f Enable® Aortic Bioprosthesis (Model 6000)
Aortic Valve Replacement surgery of the native aortic valve with the Enable® aortic bioprosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Aortic valve stenosis, aortic valve insufficiency | Patients with aortic valve insufficiency and/or aortic valve stenosis who require AVR. Receives: Procedure: Aortic Valve Replacement surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Clinical performance during implant procedure, at 30 days post-implant (or prior to hospital discharge, whatever comes first), within 6 months post-operation, 1 year and annually thereafter up to 5 years post-procedure.
The early and late (up to five years) clinical performance of the Enable® aortic bioprosthesis will be characterized. Measures of clinical performance will include hemodynamic performance by echocardiography, New York Heart Association (NYHA) Functional Classification and safety (SAEs, ADEs, SADEs).
Measured: During implant procedure, at 30 days post-implant (or prior to hospital discharge, whatever comes first), within 6 months post-operation, 1 year and annually thereafter up to 5 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 posted2 Nov 2012 (estimated)
- Study startFeb 2013
- Primary completionApr 2018
- Study completionApr 2018
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
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Otto Dapunt, MD, Principal investigator, LKH Universitätsklinik Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720342
- Sponsor's protocol ID
- EASE Enable
- Acronym
- EASE
- Status last verified
- Apr 2019
- First submitted
- 22 Oct 2012
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- 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 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enable® Aortic Sutureless Bioprosthesis Evaluation: A Post-market Release Non-interventional Study
- ClinicalTrials.gov ID
- NCT01720342
- Acronym / sponsor ID
- EASE / EASE Enable
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- Keywords
- Medtronic Enable® aortic bioprosthesis, Aortic valve stenosis, Aortic valve insufficiency, "Real world" patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 2 Nov 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.
The EASE Enable study is intended to collect additional data on the clinical outcomes of the Medtronic Enable® Aortic Bioprosthesis in "real world" patients.
Detailed description
The EASE Enable study is intended to characterize the clinical performance of the Medtronic Enable® aortic bioprosthesis in a post-market real-world setting.
This is a Non-randomized, prospective, non-interventional multi-center post-market release (PMR) study. Up to 800 subjects will be enrolled at up to 40 centers in Europe. After aortic valve replacement with the Enable® aortic bioprosthesis, each patient will have routine follow-up visits at the following intervals: at 30 days post-implant (at 30 days post-implant or prior to hospital discharge, whatever comes first), within 6 months following implantation, 1 year and annually thereafter up to 5 years post-implant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortic valve stenosis, aortic valve insufficiency | – | Procedure: Aortic Valve Replacement surgeryPatients with aortic valve insufficiency and/or aortic valve stenosis who require AVR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with aortic valve stenosis, aortic valve insufficiency or a combination of the two who require aortic valve replacement are eligible for this study, if they meet all study inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (5 listed)
- Patient with aortic valve stenosis, aortic valve insufficiency or a combination of the two.
- Patient requires replacement of his/her native aortic valve with a bioprosthesis with or without concomitant procedures.
- Patient is above the minimum age as required by local regulations to be participating in a clinical study.
- Patient is willing to return to the implant site for follow-up visits.
- Patient has been adequately informed of this clinical study and is willing to sign the patient Data Release Form.
Key exclusion criteria (5 listed)
- Patient requires replacement of two or more valves.
- Patient who underwent previous aortic valve replacement (AVR).
- Patient with native bicuspid aortic valve.
- Patient with active endocarditis or other systemic infection.
- Patient dilatation of the ascending aorta, deformations or irregular aortic annulus or ascending aorta geometry as seen via preoperative imaging.
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 Replacement surgeryAlso: Medtronic ATS 3f Enable® Aortic Bioprosthesis (Model 6000)Aortic Valve Replacement surgery of the native aortic valve with the Enable® aortic bioprosthesis. | Procedure or surgery | Aortic valve stenosis, aortic valve insufficiency |
Primary outcome
Change from Baseline in Clinical performance during implant procedure, at 30 days post-implant (or prior to hospital discharge, whatever comes first), within 6 months post-operation, 1 year and annually thereafter up to 5 years post-procedure.
Time frame: During implant procedure, at 30 days post-implant (or prior to hospital discharge, whatever comes first), within 6 months post-operation, 1 year and annually thereafter up to 5 years post-procedure.
The early and late (up to five years) clinical performance of the Enable® aortic bioprosthesis will be characterized. Measures of clinical performance will include hemodynamic performance by echocardiography, New York Heart Association (NYHA) Functional Classification and safety (SAEs, ADEs, SADEs).
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.
- 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.
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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.
Otto Dapunt, MD principal investigator
LKH Universitätsklinik Graz, Austria
17 sites in 7 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 17 sites in 7 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 5 inclusion and 5 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 17 sites in Germany, Italy, France, Netherlands, Spain and 2 more countries. 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?
Change from Baseline in Clinical performance during implant procedure, at 30 days post-implant (or prior to hospital discharge, whatever comes first), within 6 months post-operation, 1 year and annually thereafter up to 5 years post-procedure. (time frame: During implant procedure, at 30 days post-implant (or prior to hospital discharge, whatever comes first), within 6 months post-operation, 1 year and annually thereafter up to 5 years post-procedure.). 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 NCT01720342, 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 1 May 2019.