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Assessment of Sustained Systolic-to-diastolic Flexibility of the Mitral Valve Annulus With the Sorin MEMO 3D Mitral Anuloplasty Ring (MEMO 3D)

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ClinicalTrials.gov Identifier: NCT01987635
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : November 19, 2013
Last Update Posted : December 5, 2014
Sponsor:
Collaborator:
LivaNova
Information provided by (Responsible Party):
University Hospital, Ghent

Brief 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 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.


Condition or disease Intervention/treatment Phase
Mitral Valve Disease Device: MEMO 3D ring Device: Standard use of rigid ring. Procedure: 3D Echocardiography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Sustained Systolic-to-diastolic Flexibility of the Mitral Valve Annulus With the Sorin MEMO 3D Mitral Anuloplasty Ring
Study Start Date : January 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: MEMO 3D anuloplasty ring
MEMO 3D anuloplasty ring
Device: MEMO 3D ring
The experimental MEMO 3D ring is placed.

Procedure: 3D Echocardiography
Active Comparator: rigid ring
rigid ring
Device: Standard use of rigid ring.
The rigid ring is placed, which is standard procedure.

Procedure: 3D Echocardiography



Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987635


Contacts
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Contact: Guy Vandenplas, MD Guy.Vandenplas@ugent.be
Contact: Thierry Bové, MD Thierry.Bove@ugent.be

Locations
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Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Thierry Bové, MD       Thierry.Bove@ugent.be   
Principal Investigator: Guy Vandenplas, MD         
Sub-Investigator: Thierry Bové, MD         
Sub-Investigator: Stefan Bouchez, MD         
Sub-Investigator: Frank Timmermans, MD         
Sponsors and Collaborators
University Hospital, Ghent
LivaNova
Investigators
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Principal Investigator: Guy Vandenplas, MD University Hospital, Ghent
Additional Information:
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01987635    
Other Study ID Numbers: 2013/900
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Keywords provided by University Hospital, Ghent:
Mitral valve disease
primarily regurgitation
necessitating surgical repair
Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases