Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerative Mitral Valve Disease
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Mitral regurgitation degree measure
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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
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: 1. Measuring the required length of the chordae. 2. Forming the loops. 3. Fixation of the group of loops to the papillary muscles. 4. Fixation of the chordal loops to the free edge of the valve. 5. 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: 1. Selection of the secondary chordae. 2. Fixation of secondary chordae to the free edge of the valve. 3. Annuloplasty support ring and hydraulic test to confirm the absence of prolapse.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Mitral regurgitation degree measure
Time Frame: Two weeks
Mitral regurgitation degree (from 1 to 4) assessed by echocardiography two weeks after surgery
Secondary Outcomes
- Surgical efficacy measure(One year)
- ERO measure(Two weeks)