Mitral Regurgitation
Conditions
Brief summary
The study evaluates the results of mitral valve repair with flexible band in comparison with rigid ring in patients undergoing mitral valve repair for degenerative mitral valve disease
Detailed description
Currently, mitral ring selection is based on a surgeon's preference rather than evidence. Semirigid rings combine flexibility and stability; however, their clinical benefit has not been completely clarified. The present study aimed to compare the outcomes of mitral valve repair with a flexible posterior annuloplasty band versus complete semirigid ring in patients with degenerative mitral valve disease.
Interventions
PROCEDUREMitral valve repair
Mitral valve repair with standard technique: resection of prolapsed leaflet and/or artificial neochordae implantation
DEVICERing annuloplasty with posterior band
Mitral valve annuloplasty using Cardiamed (Penza, Russia) flexible posterior annuloplasty band
DEVICERing annuloplasty with complete ring
Mitral valve annuloplasty using Cardiamed (Penza, Russia) complete semirigid ring
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* severe primary mitral regurgitation due to degenerative mitral valve disease
Exclusion criteria
* previous open cardiac surgery, * indication for concomitant aortic valve replacement, * left ventricle impairment (ejection fraction \< 40%).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from significant mitral regurgitation | 12 months | Significant mitral regurgitation is defined as moderate and severe mitral regurgitation. The severity of MR was evaluated and defined in accordance with the European Association of Echocardiography recommendations for the assessment of valvular regurgitation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 12 months, 24 months | Continued existence at follow up |
| Freedom from reoperations | 12 months, 24 months | Freedom from redo mitral valve surgery during follow up |
| Freedom from severe MR recurrence | 12 months | The severity of MR was evaluated and defined in accordance with the European Association of Echocardiography recommendations for the assessment of valvular regurgitation |
Outcome results
None listed