Hypertrophic CardiomyopathyMVMSMNCT03906734
Mitral Valve Management During Septal Myectomy
A study testing Septal myectomy, alfieri stich and Subvalvular intervention in people with Hypertrophic Cardiomyopathy, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Objective of the study: to evaluate whether alfieri technique improves clinical and hemodynamic results compared to transaortic mitral valve secondary cord cutting in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- Septal myectomy, alfieri stich and Subvalvular intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteRussia
- Study dates
- 10 Jan 2016to 20 Mar 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertrophic obstructive cardiomyopathy
- Left ventricle outflow tract gradient > 50 mm Hg at rest
- Systolic anterior motion mediated mitral regurgitation
Who cannot join
- Intrinsic valvular heart disease
- Coronary artery disease
- Aortic disease
Trial locations and contacts
1 site in 1 country.
Russia1 site
Novosibirsk State Research Institute of Circulation Pathology
Novosibirsk, 630055
About this study
Official title: Alfieri Stich Versus Secondary Cord Cutting During Septal Myectomy in Patients With Hypertrophic Obstructive Cardiomyopathy: A Pilot Randomized Trial
Objective of the study: to evaluate whether alfieri technique improves clinical and hemodynamic results compared to transaortic mitral valve secondary cord cutting in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.
Read the detailed description
There is pilot prospective randomised study comparing immediate and early results of additional subvalvular mitral apparatus intervention versus additional alfieri stich in patients scheduled to septal myectomy for symptomatic obstructive cardiomyopathy.
Patients with proven hypertrophic cardiomyopathy and resting left ventricle outflow tract obstruction underwent septal myectomy. If patients were suitable for both surgical techniques, they were randomized to alfieri stich or secondary cord cutting. All surgeons were experienced at least 50 related procedures.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- Septal myectomy, alfieri stich, Subvalvular intervention
- Keywords
- septal myectomy, hypertrophic cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Septal myectomyProcedure or surgery
Transaortic septal myectomy
alfieri stichProcedure or surgery
Transaortic Mitral valve repair using alfieri technique
Subvalvular interventionProcedure or surgery
Transaortic Mitral valve subvalvular intervention including anterior mitral leaflet secondary cord cutting, papillary muscle release
| Study group | Role | What they receive |
|---|---|---|
| alfieri technique + Septal myectomy | Experimental | Septal myectomy plus mitral valve repair using alfieri stich Receives: Procedure: Septal myectomy; Procedure: alfieri stich |
| Subvalvular intervention + Septal myectomy | Active comparator | Septal myectomy plus subvalvular mitral valve intervention Receives: Procedure: Septal myectomy; Procedure: Subvalvular intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transmitral pressure gradient
Transmitral pressure gradient after the procedures assessed by echocardiography
Measured: 30-days
Secondary outcomes (3)
Repeat bypass
Rate of second cross clamping and repeating bypass for procedure related reasons
Measured: 30 day
Residual left ventricle outflow tract gradient
Residual left ventricle outflow tract gradient assessed by direct measurement
Measured: intraoperative measuerment
Early mortality
All cause death during 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start10 Jan 2016
- Primary completion28 Oct 2016
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies 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
- None (open label)
- Enrolment
- 48 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
- NCT03906734
- Sponsor's protocol ID
- 2017-01-12-3.1
- Acronym
- MVMSM
- Status last verified
- Apr 2019
- First submitted
- 20 Jan 2019
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Restricted by local policy
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alfieri Stich Versus Secondary Cord Cutting During Septal Myectomy in Patients With Hypertrophic Obstructive Cardiomyopathy: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT03906734
- Acronym / sponsor ID
- MVMSM / 2017-01-12-3.1
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- septal myectomy, hypertrophic cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 10 Jan 2016 (actual)
- Primary completion
- 28 Oct 2016 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 8 Apr 2019 (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.
Objective of the study: to evaluate whether alfieri technique improves clinical and hemodynamic results compared to transaortic mitral valve secondary cord cutting in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.
Detailed description
There is pilot prospective randomised study comparing immediate and early results of additional subvalvular mitral apparatus intervention versus additional alfieri stich in patients scheduled to septal myectomy for symptomatic obstructive cardiomyopathy.
Patients with proven hypertrophic cardiomyopathy and resting left ventricle outflow tract obstruction underwent septal myectomy. If patients were suitable for both surgical techniques, they were randomized to alfieri stich or secondary cord cutting. All surgeons were experienced at least 50 related procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alfieri technique + Septal myectomy | Experimental | Procedure: Septal myectomy, Procedure: alfieri stichSeptal myectomy plus mitral valve repair using alfieri stich |
| Subvalvular intervention + Septal myectomy | Active comparator | Procedure: Septal myectomy, Procedure: Subvalvular interventionSeptal myectomy plus subvalvular mitral valve intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hypertrophic obstructive cardiomyopathy
- Left ventricle outflow tract gradient > 50 mm Hg at rest
- Systolic anterior motion mediated mitral regurgitation
Key exclusion criteria (3 listed)
- Intrinsic valvular heart disease
- Coronary artery disease
- Aortic disease
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 |
|---|---|---|
| Septal myectomyTransaortic septal myectomy | Procedure or surgery | Subvalvular intervention + Septal myectomy, alfieri technique + Septal myectomy |
| alfieri stichTransaortic Mitral valve repair using alfieri technique | Procedure or surgery | alfieri technique + Septal myectomy |
| Subvalvular interventionTransaortic Mitral valve subvalvular intervention including anterior mitral leaflet secondary cord cutting, papillary muscle release | Procedure or surgery | Subvalvular intervention + Septal myectomy |
Primary outcome
Transmitral pressure gradient
Time frame: 30-days
Transmitral pressure gradient after the procedures assessed by echocardiography
3 secondary outcomes
Repeat bypass
Time frame: 30 day
Residual left ventricle outflow tract gradient
Time frame: intraoperative measuerment
Early mortality
Time frame: 30 days
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 8 Apr 2019.
- Individual participant dataSharing planned: No. Restricted by local policy
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Septal myectomy, alfieri stich and Subvalvular intervention in people with Hypertrophic Cardiomyopathy, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 3 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 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Transmitral pressure gradient (time frame: 30-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2019.