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NCT Number: NCT03674593

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiology Research Institute, Tomsk NRMC

Tomsk, 634012, Russia

About this study

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:

  • Measuring the required length of the chordae.
  • Forming the loops.
  • Fixation of the group of loops to the papillary muscles.
  • Fixation of the chordal loops to the free edge of the valve.
  • 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:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Isolated type II mitral valve insufficiency by A. Carpentier
  • Mitral regurgitation degree >2
  • Age >18 years
  • Signed informed consent to participate in the study

Exclusion criteria

  • Any other cardiac surgeries
  • Age <18 years
  • Multiple organ failure
  • ReDo procedure
  • Persistent atrial fibrillation
  • Acute infective endocarditis
  • Refusal to sign informed consent

Treatment and study plan

Mitral valve chordae prosthesis

Procedure

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

Mitral valve chordae translocation

Procedure

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

Primary outcomes

  1. Mitral regurgitation degree measure

    Time frame: Two weeks

    Mitral regurgitation degree (from 1 to 4) assessed by echocardiography two weeks after surgery

Secondary outcomes

  1. Surgical efficacy measure

    Time frame: One year

    Mitral regurgitation degree (from 1 to 4) assessed by echocardiography one year after surgery

  2. ERO measure

    Time frame: Two weeks

    Effective regurgitant orifice (ERO) (in square millimeters) assessed by echocardiography two weeks after surgery

Sponsors and collaborators

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Other

Registry information

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Sep 17, 2018
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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