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

NCT01987635 | Completed

• 1 other identifier: 2013/900
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Valve Disease

Keywords

Mitral valve disease; primarily regurgitation; necessitating surgical repair

Outcome Measures

Primary Outcomes (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.

  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

  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

  1 year after implantation.

Study Arms (2)

MEMO 3D anuloplasty ring

EXPERIMENTAL

MEMO 3D anuloplasty ring

Device: MEMO 3D ring; Procedure: 3D Echocardiography

rigid ring

ACTIVE COMPARATOR

rigid ring

Device: Standard use of rigid ring.; Procedure: 3D Echocardiography

Interventions

MEMO 3D ring DEVICE

The experimental MEMO 3D ring is placed.

MEMO 3D anuloplasty ring

Standard use of rigid ring. DEVICE

The rigid ring is placed, which is standard procedure.

rigid ring

3D Echocardiography PROCEDURE

MEMO 3D anuloplasty ring; rigid ring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University Hospital, Ghent: lead
• LivaNova: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Links

• Related Info

Study Officials

• Guy Vandenplas, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 19, 2013
• Study Start: January 16, 2014
• Primary Completion: September 13, 2016
• Study Completion: September 28, 2018
• Last Updated: December 9, 2022

Record last verified: 2022-12

Locations

BE (1)