Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Measuring the required length of the chordae. Forming the loops. Fixation of the group of loops to the papillary muscles. Fixation of the chordal loops to the free edge of the valve. Annuloplasty with a support ring and a hydraulic test to confirm the absence of prolapse. 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: Selection of the secondary chordae. Fixation of secondary chordae to the free edge of the valve. Annuloplasty support ring and hydraulic test to confirm the absence of prolapse.

Official Title
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Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae

Conditions
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Degenerative Mitral Valve Disease

Intervention / Treatment
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* Procedure: Mitral valve chordae prosthesis
* Procedure: Mitral valve chordae translocation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Isolated type II mitral valve insufficiency by A. Carpentier Mitral regurgitation degree >2 Age >18 years Signed informed consent to participate in the study Exclusion Criteria: Any other cardiac surgeries Age <18 years Multiple organ failure ReDo procedure Persistent atrial fibrillation Acute infective endocarditis Refusal to sign informed 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-center, prospective, semi-open, randomized study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitral valve chordae prosthesis<br>Patients of this group receive mitral valve chordae replacement performed in five stages: Measure the required length of the chordae. Forming loops. Fixation of the loop group to the papillary muscles. Fixation of chordal loops to the free edge of the valve. Annuloplasty with a support ring and a hydraulic test to confirm the absence of prolapse. | Procedure: Mitral valve chordae prosthesis<br>* The method consists of five stages: Measure the required length of the chords Forming loops Fixation of the loop group to the papillary muscles Fixation of chordal loops to the free edge of the valve Annuloplasty with a support ring and a hydraulic test to confirm the absence of prolapse<br>* Other names: Chordae prosthesis;|
| Active Comparator: Mitral valve chordae translocation<br>The technique of translocation of secondary chordae: The method consists essentially of three stages: Selection of the secondary chordae. Fixation of secondary chordae to the free edge of the valve. Annuloplasty support ring and hydraulic test to confirm the absence of prolapse. | Procedure: Mitral valve chordae translocation<br>* The method consists essentially of three stages: Selection of the secondary chord. Fixation of secondary chords to the free edge of the valve. Annuloplasty support ring and hydraulic test to confirm the absence of prolapse.<br>* Other names: Chordae translocation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mitral regurgitation degree measure | Mitral regurgitation degree (from 1 to 4) assessed by echocardiography two weeks after surgery | Two weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | Two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitral Valve Chordae, Degenerative Mitral Valve Disease, Mitral Valve Chordae Replacement, Mitral Valve Chordae Translocation, Mitral Valve Chordae Prosthetics