Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae
NCT ID: NCT03674593
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
64 participants
INTERVENTIONAL
2018-07-09
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mitral valve chordae prosthesis
Patients of this group receive mitral valve chordae replacement performed in five stages:
1. Measure the required length of the chordae.
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.
Mitral 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
Mitral valve chordae translocation
The technique of translocation of secondary chordae:
The method consists essentially 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.
Mitral 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.
Interventions
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Mitral 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
Mitral 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Mitral regurgitation degree \>2
3. Age \>18 years
4. Signed informed consent to participate in the study
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Tomsk National Research Medical Center of the Russian Academy of Sciences
OTHER
Responsible Party
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Principal Investigators
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Elena N. Pavlyukova, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Tomsk NRMC
Locations
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Cardiology Research Institute, Tomsk NRMC
Tomsk, , Russia
Countries
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Other Identifiers
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Mitral Valve Chordae
Identifier Type: -
Identifier Source: org_study_id
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