Mitral Valve DiseaseMEMO 3DNCT01987635
Assessment of Sustained Systolic-to-diastolic Flexibility of the Mitral Valve Annulus With the Sorin MEMO 3D Mitral Anuloplasty Ring
A study testing MEMO 3D ring, Standard use of rigid ring. and 3D Echocardiography in people with Mitral Valve Disease, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Mitral valve reconstruction commonly requires the use of an anuloplasty device to assure long-term durability of the repair. Among mitral anuloplasty devices, varying from rigid to complete flexible ring substitutes, the most recent ones are aimed to restore the natural saddle shape of the mitral annulus, in order to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Disease
- What is being tested?
- MEMO 3D ring, Standard use of rigid ring. and 3D Echocardiography
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Jan 2014to 28 Sep 2018
- Phase
- Interventional
- 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
Who may be able to join
- All patients requiring the use of an mitral anuloplasty device to restore the mitral competence by surgery are potential candidates for study inclusion, if survival of at least more than 1 year is expected
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Mitral valve reconstruction commonly requires the use of an anuloplasty device to assure long-term durability of the repair. Among mitral anuloplasty devices, varying from rigid to complete flexible ring substitutes, the most recent ones are aimed to restore the natural saddle shape of the mitral annulus, in order to decrease the stress tension on both mitral leaflets and chordal attachments. So far, even for flexible ring devices, the sustained flexibility of the device remained unproven, probably by cicatricial fibrotic tissue ingrowth after implantation.
Due to specific structural characteristics based on a nitinolstent with carbofilm-coating, the MEMO 3D ring device of SORIN claims preservation of the ring flexibility during the cardiac cyclus. Consequently, mitral anuloplasty with this device is expected to decrease the stress during the systolo-diastolic movements of the valve, and so, improve the late durability of the repair.
Read more
Echocardiography is the first-line technique for mitral valve assessment after surgical repair, for both intra-operative evaluation and serial follow-up of valve function. Recently, three-dimensional echocardiography has been introduced into clinical practice, affording qualitative and quantitative measurement of mitral valve function and size during the cardiac cycle.This method allows to quantify precisely the excursion of the mitral annulus between systole and diastole.
The aim of this study is to analyse the systolo-diastolic movement of the mitral annulus after the use of an anuloplasty with the SORIN MEMO 3D device, after surgical implantation and its sustainability, 1 year after implantation.
This hypothesis is tested in a case-controlled comparison with a standard used rigid ring device.
Therefore, 3-D echocardiography will be performed at the time of surgical repair, and after 1 year, to define the size and surface change of the mitral anuloplasty device during the cardiac cycle.
Based on a sample size calculation, 10 patients in each comparison group will be included, suggesting a study cohort of 20 patients eligible for mitral valve repair.
- Conditions
- Mitral Valve Disease
- Being tested
- MEMO 3D ring, Standard use of rigid ring., 3D Echocardiography
- Keywords
- Mitral valve disease, primarily regurgitation, necessitating surgical repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEMO 3D ringDevice
The experimental MEMO 3D ring is placed.
Standard use of rigid ring.Device
The rigid ring is placed, which is standard procedure.
3D EchocardiographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| MEMO 3D anuloplasty ring | Experimental | MEMO 3D anuloplasty ring Receives: Device: MEMO 3D ring; Procedure: 3D Echocardiography |
| rigid ring | Active comparator | rigid ring Receives: Device: Standard use of rigid ring.; Procedure: 3D Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of diameters and surface of the anuloplasty device between systolic and diastolic phase of the cardiac cycle in the MEMO 3D device, compared to another rigid ring device.
Difference of antero-posterior diameter, latero-lateral diameter and surface of the anuloplasty device between systolic and diastolic phase of the cardiac cycle in the MEMO 3D device, compared to another rigid ring device. The measurements are done with the use of 3-D echocardiography
Measured: intra-operatively
Difference of diameters and surface of the anuloplasty device between systolic and diastolic phase of the cardiac cycle in the MEMO 3D device, compared to another rigid ring device.
Difference of antero-posterior diameter, latero-lateral diameter and surface of the anuloplasty device between systolic and diastolic phase of the cardiac cycle in the MEMO 3D device, compared to another rigid ring device. The measurements are done with the use of 3-D echocardiography
Measured: 1 year after implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study start16 Jan 2014
- Primary completion13 Sep 2016
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- LivaNova
- Responsible party
- Sponsor
- Investigators
- Guy Vandenplas, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987635
- Sponsor's protocol ID
- 2013/900
- Acronym
- MEMO 3D
- Status last verified
- Dec 2022
- First submitted
- 12 Nov 2013
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sustained Systolic-to-diastolic Flexibility of the Mitral Valve Annulus With the Sorin MEMO 3D Mitral Anuloplasty Ring
- ClinicalTrials.gov ID
- NCT01987635
- Acronym / sponsor ID
- MEMO 3D / 2013/900
- Conditions
- Mitral Valve Disease
- Keywords
- Mitral valve disease, primarily regurgitation, necessitating surgical repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- LivaNova
- Study start
- 16 Jan 2014 (actual)
- Primary completion
- 13 Sep 2016 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 19 Nov 2013 (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.
Mitral valve reconstruction commonly requires the use of an anuloplasty device to assure long-term durability of the repair. Among mitral anuloplasty devices, varying from rigid to complete flexible ring substitutes, the most recent ones are aimed to restore the natural saddle shape of the mitral annulus, in order to decrease the stress tension on both mitral leaflets and chordal attachments. So far, even for flexible ring devices, the sustained flexibility of the device remained unproven, probably by cicatricial fibrotic tissue ingrowth after implantation.
Due to specific structural characteristics based on a nitinolstent with carbofilm-coating, the MEMO 3D ring device of SORIN claims preservation of the ring flexibility during the cardiac cyclus. Consequently, mitral anuloplasty with this device is expected to decrease the stress during the systolo-diastolic movements of the valve, and so, improve the late durability of the repair.
Echocardiography is the first-line technique for mitral valve assessment after surgical repair, for both intra-operative evaluation and serial follow-up of valve function. Recently, three-dimensional echocardiography has been introduced into clinical practice, affording qualitative and quantitative measurement of mitral valve function and size during the cardiac cycle.This method allows to quantify precisely the excursion of the mitral annulus between systole and diastole.
The aim of this study is to analyse the systolo-diastolic movement of the mitral annulus after the use of an anuloplasty with the SORIN MEMO 3D device, after surgical implantation and its sustainability, 1 year after implantation.
This hypothesis is tested in a case-controlled comparison with a standard used rigid ring device.
Therefore, 3-D echocardiography will be performed at the time of surgical repair, and after 1 year, to define the size and surface change of the mitral anuloplasty device during the cardiac cycle.
Based on a sample size calculation, 10 patients in each comparison group will be included, suggesting a study cohort of 20 patients eligible for mitral valve repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEMO 3D anuloplasty ring | Experimental | Device: MEMO 3D ring, Procedure: 3D EchocardiographyMEMO 3D anuloplasty ring |
| rigid ring | Active comparator | Device: Standard use of rigid ring., Procedure: 3D Echocardiographyrigid ring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients requiring the use of an mitral anuloplasty device to restore the mitral competence by surgery are potential candidates for study inclusion, if survival of at least more than 1 year is expected
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MEMO 3D ringThe experimental MEMO 3D ring is placed. | Device | MEMO 3D anuloplasty ring |
| Standard use of rigid ring.The rigid ring is placed, which is standard procedure. | Device | rigid ring |
| 3D Echocardiography | Procedure or surgery | MEMO 3D anuloplasty ring, rigid ring |
Primary outcome
Difference of diameters and surface of the anuloplasty device between systolic and diastolic phase of the cardiac cycle in the MEMO 3D device, compared to another rigid ring device.
Time frame: intra-operatively
Difference of antero-posterior diameter, latero-lateral diameter and surface of the anuloplasty device between systolic and diastolic phase of the cardiac cycle in the MEMO 3D device, compared to another rigid ring device. The measurements are done with the use of 3-D echocardiography
Difference of diameters and surface of the anuloplasty device between systolic and diastolic phase of the cardiac cycle in the MEMO 3D device, compared to another rigid ring device.
Time frame: 1 year after implantation.
Difference of antero-posterior diameter, latero-lateral diameter and surface of the anuloplasty device between systolic and diastolic phase of the cardiac cycle in the MEMO 3D device, compared to another rigid ring device. The measurements are done with the use of 3-D echocardiography
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 9 Dec 2022.
- Related InfoLink 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.
Guy Vandenplas, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEMO 3D ring, Standard use of rigid ring. and 3D Echocardiography in people with Mitral Valve Disease, run by University Hospital, Ghent at 1 site in Belgium.
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 1 inclusion and 0 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 9 Dec 2022. 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 Belgium. 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?
Difference of diameters and surface of the anuloplasty device between systolic and diastolic phase of the cardiac cycle in the MEMO 3D device, compared to another rigid ring device. (time frame: intra-operatively). The study lists 2 primary outcomes in all. 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 9 Dec 2022.