Physiological Changes of the Mitral Annulus After Annuloplasty in Barlow Disease

Study Overview
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Brief Summary
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Barlow disease (BD) is a common cause of mitral insufficiency. In 2012 the University Hospital of Basel started to perform a simplified mitral valve repair technique in BD just by implanting an annuloplasty-ring. It is hypothesized that the major mechanism of the valvular insufficiency in Barlow disease is a deformation of the left ventricle and the posterior mitral annulus, causing its aberrant displacement during the systole towards posterior and basal and thus impairing the coaptation of the leaflets. This prospective individual MRI study is to investigate the ventricle and the mitral annulus pre- and postoperatively for detailed analysis.

Official Title
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Physiological Changes of the Mitral Annulus After Annuloplasty in Barlow Disease: an MRI-focused Study

Conditions
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Barlow Disease (BD), Mitral Insufficiency

Intervention / Treatment
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* Diagnostic Test: Magnetic resonance imaging (MRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: identified Barlow disease suffering from significant mitral insufficiency with indication to surgery Exclusion Criteria: Active endocarditis or any other etiology of mitral insufficiency else than Barlow disease Inability to perform a cardiac MRI (e.g., metallic implants, claustrophobia) Pregnancy Inability to give consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Magnetic resonance imaging (MRI)|MRI pre- and postoperatively for detailed analysis of the ventricle and the mitral annulus. The first MRI will be performed on the admission day before surgery. The second MRI will be performed during the hospital stay, between 3 and 7 days after the operation. The MRI images are interpreted through a specialized cardiologist and radiologist.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anatomical structures by MRI | Change in anatomical structures by MRI: distance (mm) between the mitral annulus and the cardiac apex during the cardiac cycle before and after surgical correction | The first MRI will be performed on the admission day before surgery. The second MRI will be performed during the hospital stay, between 3 and 7 days after the operation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| function of the mitral valve by echocardiography | association between reduction of movement of the posterior annulus and the function of the valve after surgery (i.e. its residual insufficiency (0 = absent, 1 = mild, 2 = moderate, 3 = severe)). Evaluated with echocardiography as it is routinely performed in cardiac surgery. | during the hospital stay, between 3 and 7 days after the operation and at cardiological follow-up over the first 3 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mitral annuloplasty, mitral valve repair, mitral annulus, coaptation of mitral leaflets