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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03674593
Other study ID # Mitral Valve Chordae
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 9, 2018
Est. completion date December 31, 2026

Study information

Verified date December 2023
Source Tomsk National Research Medical Center of the Russian Academy of Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 64
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Mitral valve chordae prosthesis
The method consists of five stages: Measure the required length of the chords Forming loops Fixation of the loop group to the papillary muscles Fixation of chordal loops to the free edge of the valve 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: Selection of the secondary chord. Fixation of secondary chords to the free edge of the valve. Annuloplasty support ring and hydraulic test to confirm the absence of prolapse.

Locations

Country Name City State
Russian Federation Cardiology Research Institute, Tomsk NRMC Tomsk

Sponsors (1)

Lead Sponsor Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mitral regurgitation degree measure Mitral regurgitation degree (from 1 to 4) assessed by echocardiography two weeks after surgery Two weeks
Secondary Surgical efficacy measure Mitral regurgitation degree (from 1 to 4) assessed by echocardiography one year after surgery One year
Secondary ERO measure Effective regurgitant orifice (ERO) (in square millimeters) assessed by echocardiography two weeks after surgery Two weeks
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