Mitral RegurgitationNCT03278574
Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease
A study testing Mitral valve repair, Ring annuloplasty with posterior band and Ring annuloplasty with complete ring in people with Mitral Regurgitation, run by Meshalkin Research Institute of Pathology of Circulation.
Trial summary
The study evaluates the results of mitral valve repair with flexible band in comparison with rigid ring in patients undergoing mitral valve repair for degenerative mitral valve disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- Mitral valve repair, Ring annuloplasty with posterior band and Ring annuloplasty with complete ring
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2011to 26 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- severe primary mitral regurgitation due to degenerative mitral valve disease
Who cannot join
- previous open cardiac surgery,
- indication for concomitant aortic valve replacement,
- left ventricle impairment (ejection fraction < 40%).
About this study
Official title: Mitral Valve Repair Using Flexible Bands Versus Complete Rings in Patients With Degenerative Mitral Valve Disease: a Prospective, Randomized Study
The study evaluates the results of mitral valve repair with flexible band in comparison with rigid ring in patients undergoing mitral valve repair for degenerative mitral valve disease
Read the detailed description
Currently, mitral ring selection is based on a surgeon's preference rather than evidence. Semirigid rings combine flexibility and stability; however, their clinical benefit has not been completely clarified. The present study aimed to compare the outcomes of mitral valve repair with a flexible posterior annuloplasty band versus complete semirigid ring in patients with degenerative mitral valve disease.
- Conditions
- Mitral Regurgitation
- Being tested
- Mitral valve repair, Ring annuloplasty with posterior band, Ring annuloplasty with complete ring
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral valve repairProcedure or surgery
Mitral valve repair with standard technique: resection of prolapsed leaflet and/or artificial neochordae implantation
Ring annuloplasty with posterior bandDevice
Mitral valve annuloplasty using Cardiamed (Penza, Russia) flexible posterior annuloplasty band
Ring annuloplasty with complete ringDevice
Mitral valve annuloplasty using Cardiamed (Penza, Russia) complete semirigid ring
| Study group | Role | What they receive |
|---|---|---|
| Flexible band | Experimental | Mitral valve repair with flexible posterior annuloplasty band Receives: Procedure: Mitral valve repair; Device: Ring annuloplasty with posterior band |
| Complete ring | Active comparator | Mitral valve repair with complete rigid ring Receives: Procedure: Mitral valve repair; Device: Ring annuloplasty with complete ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from significant mitral regurgitation
Significant mitral regurgitation is defined as moderate and severe mitral regurgitation. The severity of MR was evaluated and defined in accordance with the European Association of Echocardiography recommendations for the assessment of valvular regurgitation
Measured: 12 months
Secondary outcomes (3)
Survival
Continued existence at follow up
Measured: 12 months, 24 months
Freedom from reoperations
Freedom from redo mitral valve surgery during follow up
Measured: 12 months, 24 months
Freedom from severe MR recurrence
The severity of MR was evaluated and defined in accordance with the European Association of Echocardiography recommendations for the assessment of valvular regurgitation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start5 Sep 2011
- Primary completion29 Sep 2014
- Study completion26 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278574
- Sponsor's protocol ID
- 25041214
- Status last verified
- Sep 2017
- First submitted
- 6 Sep 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data is unavailable for security reason
Publications
Bogachev-Prokophiev AV, Afanasyev AV, Zheleznev SI, Nazarov VM, Sharifulin RM, Karaskov AM. Mid-term results of mitral valve repair using flexible bands versus complete rings in patients with degenerative mitral valve disease: a prospective, randomized study. J Cardiothorac Surg. 2017 Dec 13;12(1):113. doi: 10.1186/s13019-017-0679-0.
PubMed 29237465
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitral Valve Repair Using Flexible Bands Versus Complete Rings in Patients With Degenerative Mitral Valve Disease: a Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT03278574
- Acronym / sponsor ID
- 25041214
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 5 Sep 2011 (actual)
- Primary completion
- 29 Sep 2014 (actual)
- Study completion
- 26 Dec 2016 (actual)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates the results of mitral valve repair with flexible band in comparison with rigid ring in patients undergoing mitral valve repair for degenerative mitral valve disease
Detailed description
Currently, mitral ring selection is based on a surgeon's preference rather than evidence. Semirigid rings combine flexibility and stability; however, their clinical benefit has not been completely clarified. The present study aimed to compare the outcomes of mitral valve repair with a flexible posterior annuloplasty band versus complete semirigid ring in patients with degenerative mitral valve disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexible band | Experimental | Procedure: Mitral valve repair, Device: Ring annuloplasty with posterior bandMitral valve repair with flexible posterior annuloplasty band |
| Complete ring | Active comparator | Procedure: Mitral valve repair, Device: Ring annuloplasty with complete ringMitral valve repair with complete rigid ring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- severe primary mitral regurgitation due to degenerative mitral valve disease
Key exclusion criteria (3 listed)
- previous open cardiac surgery,
- indication for concomitant aortic valve replacement,
- left ventricle impairment (ejection fraction < 40%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitral valve repairMitral valve repair with standard technique: resection of prolapsed leaflet and/or artificial neochordae implantation | Procedure or surgery | Complete ring, Flexible band |
| Ring annuloplasty with posterior bandMitral valve annuloplasty using Cardiamed (Penza, Russia) flexible posterior annuloplasty band | Device | Flexible band |
| Ring annuloplasty with complete ringMitral valve annuloplasty using Cardiamed (Penza, Russia) complete semirigid ring | Device | Complete ring |
Primary outcome
Freedom from significant mitral regurgitation
Time frame: 12 months
Significant mitral regurgitation is defined as moderate and severe mitral regurgitation. The severity of MR was evaluated and defined in accordance with the European Association of Echocardiography recommendations for the assessment of valvular regurgitation
3 secondary outcomes
Survival
Time frame: 12 months, 24 months
Freedom from reoperations
Time frame: 12 months, 24 months
Freedom from severe MR recurrence
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Derived from this study: PubMed 29237465Bogachev-Prokophiev AV, Afanasyev AV, Zheleznev SI, Nazarov VM, Sharifulin RM, Karaskov AM. Mid-term results of mitral valve repair using flexible bands versus complete rings in patients with degenerative mitral valve disease: a prospective, randomized study. J Cardiothorac Surg. 2017 Dec 13;12(1):113. doi: 10.1186/s13019-017-0679-0.
- Individual participant dataSharing planned: No. individual participant data is unavailable for security reason
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mitral valve repair, Ring annuloplasty with posterior band and Ring annuloplasty with complete ring in people with Mitral Regurgitation, run by Meshalkin Research Institute of Pathology of Circulation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from significant mitral regurgitation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03278574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.