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

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status: Active, not recruiting

Conditions: Degenerative Mitral Valve Disease

Treatments: Procedure: Mitral valve chordae translocation; Procedure: Mitral valve chordae prosthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT03674593

Mitral Valve Chordae

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Mitral valve chordae prosthesis

Experimental group

Description:

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.

Treatment:

Procedure: Mitral valve chordae prosthesis

Mitral valve chordae translocation

Active Comparator group

Description:

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.

Treatment:

Procedure: Mitral valve chordae translocation