Clinical trial NCT03674593: Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae
Official title: Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Degenerative Mitral Valve Disease
Keywords: Mitral Valve Chordae
Degenerative Mitral Valve Disease
Mitral Valve Chordae Replacement
Mitral Valve Chordae Translocation
Mitral Valve Chordae Prosthetics
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, prospective, semi-open, randomized study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mitral regurgitation degree measure
timeFrame: Two weeks
Secondary outcomes:
measure: Surgical efficacy measure
timeFrame: One year
measure: ERO measure
timeFrame: Two weeks
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Cardiology Research Institute, Tomsk NRMC
Study officials:
affiliation: Tomsk NRMC
name: Elena N. Pavlyukova, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: