Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-03-03 @ 3:18 AM
Study NCT ID:
NCT03674593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-09
First Post:
2018-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae
Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Organization:
Study Overview
Official Title:
Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: