Assessment of Sustained Systolic-to-diastolic Flexibility of the Mitral Valve Annulus With the Sorin MEMO 3D Mitral Anuloplasty Ring
NCT ID: NCT01987635
Last Updated: 2022-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2014-01-16
2018-09-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MEMO 3D anuloplasty ring
MEMO 3D anuloplasty ring
MEMO 3D ring
The experimental MEMO 3D ring is placed.
3D Echocardiography
rigid ring
rigid ring
Standard use of rigid ring.
The rigid ring is placed, which is standard procedure.
3D Echocardiography
Interventions
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MEMO 3D ring
The experimental MEMO 3D ring is placed.
Standard use of rigid ring.
The rigid ring is placed, which is standard procedure.
3D Echocardiography
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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LivaNova
INDUSTRY
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Guy Vandenplas, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Ghent University Hospital
Ghent, , Belgium
Countries
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Related Links
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Related Info
Other Identifiers
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2013/900
Identifier Type: -
Identifier Source: org_study_id