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

Degenerative Mitral Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03674593
• Other study ID #: Mitral Valve Chordae
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Mitral Valve Disease
• Heart Valve Diseases

Intervention

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
• 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.

Locations

Country	Name	City	State
Russian Federation	Cardiology Research Institute, Tomsk NRMC	Tomsk

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

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