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The study compares the efficacies of two surgical procedures for the treatment of mitral valve prolapse due to myxomatous degeneration of the mitral valve: the chordae replacement and the translocation of secondary mitral valve chordae.
Summary: This study compares the efficacy and the safety of two surgical procedures for the treatment of mitral valve prolapse due to degeneration of the mitral valve: chordae replacement and the translocation of secondary mitral valve chordae.
In our study, researchers used the loop method proposed by von Oppel and Mohr in 2000. The main principle of the method of prosthetic chordae is the preservation of the native anatomy of the mitral valve. This principle is achieved by the implantation of artificial chordae made of ePTFE Gore-Tex threads.
The chordae replacement method essentially involves five stages:
Chordae translocation is the alternative method, which does not require measurement and selection of chordae lengths. Chordae replacement is technically easier (less aortic clamping time) with comparable results.
The technique of translocation of secondary chordae essentially consists of three stages:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitral valve chordae prosthesis | Experimental | Patients of this group receive mitral valve chordae replacement performed in five stages:
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| Mitral valve chordae translocation | Active Comparator | The technique of translocation of secondary chordae: The method consists essentially of three stages:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitral valve chordae prosthesis | Procedure | The method consists of five stages:
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| Measure | Description | Time Frame |
|---|---|---|
| Mitral regurgitation degree measure | Mitral regurgitation degree (from 1 to 4) assessed by echocardiography two weeks after surgery | Two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical efficacy measure | Mitral regurgitation degree (from 1 to 4) assessed by echocardiography one year after surgery | One year |
| ERO measure | Effective regurgitant orifice (ERO) (in square millimeters) assessed by echocardiography two weeks after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena N. Pavlyukova, MD, PhD | Tomsk NRMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Research Institute, Tomsk NRMC | Tomsk | 634012 | Russia |
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Single-center, prospective, semi-open, randomized study
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Single blind masking (Participant)
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| Mitral valve chordae translocation | Procedure | The method consists essentially of three stages:
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| Two weeks |