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

Primary Purpose

Degenerative Mitral Valve Disease

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Mitral valve chordae prosthesis
Mitral valve chordae translocation
Sponsored by
Tomsk National Research Medical Center of the Russian Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Mitral Valve Disease focused on measuring Mitral Valve Chordae, Degenerative Mitral Valve Disease, Mitral Valve Chordae Replacement, Mitral Valve Chordae Translocation, Mitral Valve Chordae Prosthetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiology Research Institute, Tomsk NRMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mitral valve chordae prosthesis

Mitral valve chordae translocation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 9, 2018
Last Updated
October 31, 2022
Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03674593
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 9, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Mitral Valve Disease
Keywords
Mitral Valve Chordae, Degenerative Mitral Valve Disease, Mitral Valve Chordae Replacement, Mitral Valve Chordae Translocation, Mitral Valve Chordae Prosthetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-center, prospective, semi-open, randomized study
Masking
Participant
Masking Description
Single blind masking (Participant)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mitral valve chordae prosthesis
Arm Type
Experimental
Arm Description
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.
Arm Title
Mitral valve chordae translocation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Mitral valve chordae prosthesis
Other Intervention Name(s)
Chordae prosthesis
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Mitral valve chordae translocation
Other Intervention Name(s)
Chordae translocation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mitral regurgitation degree measure
Description
Mitral regurgitation degree (from 1 to 4) assessed by echocardiography two weeks after surgery
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Surgical efficacy measure
Description
Mitral regurgitation degree (from 1 to 4) assessed by echocardiography one year after surgery
Time Frame
One year
Title
ERO measure
Description
Effective regurgitant orifice (ERO) (in square millimeters) assessed by echocardiography two weeks after surgery
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena N. Pavlyukova, MD, PhD
Organizational Affiliation
Tomsk NRMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology Research Institute, Tomsk NRMC
City
Tomsk
ZIP/Postal Code
634012
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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