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

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

Interventions

DEVICE

MEMO 3D ring

The experimental MEMO 3D ring is placed.

DEVICE

Standard use of rigid ring.

The rigid ring is placed, which is standard procedure.

PROCEDURE

3D Echocardiography

Sponsors & Collaborators

• LivaNova

  collaborator INDUSTRY

• University Hospital, Ghent

  lead OTHER

Principal Investigators

• Guy Vandenplas, MD · University Hospital, Ghent

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-16

Primary Completion

2016-09-13

Completion

2018-09-28

Countries

• Belgium

Study Locations