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

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ClinicalTrials.gov Identifier: NCT03674593
Recruitment Status : Active, not recruiting
First Posted : September 17, 2018
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Tomsk National Research Medical Center of the Russian Academy of Sciences

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.

Condition or disease Intervention/treatment Phase
Degenerative Mitral Valve Disease Procedure: Mitral valve chordae prosthesis Procedure: Mitral valve chordae translocation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-center, prospective, semi-open, randomized study
Masking: Single (Participant)
Masking Description: Single blind masking (Participant)
Primary Purpose: Treatment
Official Title: Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2022

Arm Intervention/treatment
Experimental: Mitral valve chordae prosthesis

Patients of this group receive mitral valve chordae replacement performed in five stages:

  1. Measure the required length of the chordae.
  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 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
Other Name: Chordae prosthesis

Active Comparator: Mitral valve chordae translocation

The technique of translocation of secondary chordae:

The method consists essentially 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.
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.
Other Name: Chordae translocation




Primary Outcome Measures :
  1. Mitral regurgitation degree measure [ Time Frame: Two weeks ]
    Mitral regurgitation degree (from 1 to 4) assessed by echocardiography two weeks after surgery


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674593


Locations
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Russian Federation
Cardiology Research Institute, Tomsk NRMC
Tomsk, Russian Federation, 634012
Sponsors and Collaborators
Tomsk National Research Medical Center of the Russian Academy of Sciences
Investigators
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Principal Investigator: Elena N. Pavlyukova, MD, PhD Tomsk NRMC
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Responsible Party: Tomsk National Research Medical Center of the Russian Academy of Sciences
ClinicalTrials.gov Identifier: NCT03674593    
Other Study ID Numbers: Mitral Valve Chordae
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tomsk National Research Medical Center of the Russian Academy of Sciences:
Mitral Valve Chordae
Degenerative Mitral Valve Disease
Mitral Valve Chordae Replacement
Mitral Valve Chordae Translocation
Mitral Valve Chordae Prosthetics
Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases