NCT03674593

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Degenerative Mitral Valve Disease

Interventions

Type	Name	Description
PROCEDURE	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
PROCEDURE	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.

Timeline

• Start date: 2018-07-09
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2018-09-17
• Last updated: 2025-04-09

Locations

1 site across 1 country: Russia