Degenerative Mitral Valve Disease
Conditions
Keywords
Mitral Valve Chordae, Degenerative Mitral Valve Disease, Mitral Valve Chordae Replacement, Mitral Valve Chordae Translocation, Mitral Valve Chordae Prosthetics
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.
Interventions
PROCEDUREMitral valve chordae prosthesis
The method consists of five stages: 1. Measure the required length of the chords 2. Forming loops 3. Fixation of the loop group to the papillary muscles 4. Fixation of 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
PROCEDUREMitral valve chordae translocation
The method consists essentially of three stages: 1. Selection of the secondary chord. 2. Fixation of secondary chords to the free edge of the valve. 3. Annuloplasty support ring and hydraulic test to confirm the absence of prolapse.
Sponsors
Tomsk National Research Medical Center of the Russian Academy of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single blind masking (Participant)
Intervention model description
Single-center, prospective, semi-open, randomized study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Isolated type II mitral valve insufficiency by A. Carpentier 2. Mitral regurgitation degree \>2 3. Age \>18 years 4. Signed informed consent to participate in the study
Exclusion criteria
1. Any other cardiac surgeries 2. Age \<18 years 3. Multiple organ failure 4. ReDo procedure 5. Persistent atrial fibrillation 6. Acute infective endocarditis 7. Refusal to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mitral regurgitation degree measure | Two weeks | Mitral regurgitation degree (from 1 to 4) assessed by echocardiography two weeks after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical efficacy measure | One year | Mitral regurgitation degree (from 1 to 4) assessed by echocardiography one year after surgery |
| ERO measure | Two weeks | Effective regurgitant orifice (ERO) (in square millimeters) assessed by echocardiography two weeks after surgery |
Countries
Russia
Contacts
PRINCIPAL_INVESTIGATORElena N. Pavlyukova, MD, PhD
Tomsk NRMC
Outcome results
None listed