Degenerative Mitral Valve DiseaseNCT03674593
Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae
A study testing Mitral valve chordae prosthesis and Mitral valve chordae translocation in people with Degenerative Mitral Valve Disease, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Mitral Valve Disease
- What is being tested?
- Mitral valve chordae prosthesis and Mitral valve chordae translocation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteRussia
- Study dates
- 9 Jul 2018to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Isolated type II mitral valve insufficiency by A. Carpentier
- Mitral regurgitation degree >2
- Age >18 years
- Signed informed consent to participate in the study
Who cannot join
- Any other cardiac surgeries
- Age <18 years
- Multiple organ failure
- ReDo procedure
- Persistent atrial fibrillation
- Acute infective endocarditis
- Refusal to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Degenerative Mitral Valve Disease
- Being tested
- Mitral valve chordae prosthesis, Mitral valve chordae translocation
- Keywords
- Mitral Valve Chordae, Degenerative Mitral Valve Disease, Mitral Valve Chordae Replacement, Mitral Valve Chordae Translocation, Mitral Valve Chordae Prosthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral valve chordae prosthesisProcedure or surgery
Also called 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 translocationProcedure or surgery
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Mitral valve chordae translocation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitral regurgitation degree measure
Mitral regurgitation degree (from 1 to 4) assessed by echocardiography two weeks after surgery
Measured: Two weeks
Secondary outcomes (2)
Surgical efficacy measure
Mitral regurgitation degree (from 1 to 4) assessed by echocardiography one year after surgery
Measured: One year
ERO measure
Effective regurgitant orifice (ERO) (in square millimeters) assessed by echocardiography two weeks after surgery
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start9 Jul 2018
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Mitral Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, prospective, semi-open, randomized study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena N. Pavlyukova, MD, PhD, Principal investigator, Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674593
- Sponsor's protocol ID
- CRI-163/2
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2018
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No