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

NCT03674593 | Active Not Recruiting DMC

• 1 other identifier: Mitral Valve Chordae
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Mitral Valve Disease

Keywords

Mitral Valve Chordae; Degenerative Mitral Valve Disease; Mitral Valve Chordae Replacement; Mitral Valve Chordae Translocation; Mitral Valve Chordae Prosthetics

Outcome Measures

Primary Outcomes (1)

• Mitral regurgitation degree measure

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

  Two weeks

Secondary Outcomes (2)

• Surgical efficacy measure

  One year

• ERO measure

  Two weeks

Study Arms (2)

Mitral valve chordae prosthesis

EXPERIMENTAL

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

Mitral valve chordae translocation

ACTIVE COMPARATOR

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

Interventions

Mitral valve chordae prosthesis PROCEDURE

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

Also known as: Chordae prosthesis

Mitral valve chordae prosthesis

Mitral valve chordae translocation PROCEDURE

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.

Also known as: Chordae translocation

Mitral valve chordae translocation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Cardiology Research Institute, Tomsk NRMC

Tomsk, 634012, Russia

Location

Study Officials

• Elena N. Pavlyukova, MD, PhD

  Tomsk NRMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind masking (Participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, prospective, semi-open, randomized study

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: September 17, 2018
• Study Start: July 9, 2018
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)