Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae
- Conditions
- Degenerative Mitral Valve Disease
- Interventions
- Procedure: Mitral valve chordae prosthesisProcedure: Mitral valve chordae translocation
- Registration Number
- NCT03674593
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 64
- Isolated type II mitral valve insufficiency by A. Carpentier
- Mitral regurgitation degree >2
- Age >18 years
- Signed informed consent to participate in the study
- Any other cardiac surgeries
- Age <18 years
- Multiple organ failure
- ReDo procedure
- Persistent atrial fibrillation
- Acute infective endocarditis
- Refusal to sign informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mitral valve chordae prosthesis 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 translocation 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.
- Primary Outcome Measures
Name Time Method Mitral regurgitation degree measure Two weeks Mitral regurgitation degree (from 1 to 4) assessed by echocardiography two weeks after surgery
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Cardiology Research Institute, Tomsk NRMC
🇷🇺Tomsk, Russian Federation