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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Degenerative Mitral Valve Disease
• Intervention / Treatment: Procedure: Mitral valve chordae prosthesis; Procedure: Mitral valve chordae translocation

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Tomsk, Russian Federation, 634012
    • Cardiology Research Institute, Tomsk NRMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mitral valve chordae prosthesis; Patients of this group receive mitral valve chordae replacement performed in five stages: Measure the required length of the chordae.; 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.	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; Other Names: Chordae prosthesis
Active Comparator: Mitral valve chordae translocation; The technique of translocation of secondary chordae: The method consists essentially of three stages: Selection of the secondary chordae.; Fixation of secondary chordae to the free edge of the valve.; Annuloplasty support ring and hydraulic test to confirm the absence of prolapse.	Procedure: 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.; Other Names: Chordae translocation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mitral regurgitation degree measure	Mitral regurgitation degree (from 1 to 4) assessed by echocardiography two weeks after surgery	Two weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Investigators: Principal Investigator: Elena N. Pavlyukova, MD, PhD, Tomsk NRMC

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Mitral Valve Chordae; Degenerative Mitral Valve Disease; Mitral Valve Chordae Replacement; Mitral Valve Chordae Translocation; Mitral Valve Chordae Prosthetics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: Mitral Valve Chordae

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No