Hypertrophic Obstructive CardiomyopathyPRIZMA-pilotNCT04470102
Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy
A study testing mitral valve repair by edge-to-edge technique and Septal myectomy in people with Hypertrophic Obstructive Cardiomyopathy, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Objective of the study: to evaluate whether edge-to-edge technique improves clinical and hemodynamic results 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 Obstructive Cardiomyopathy
- What is being tested?
- mitral valve repair by edge-to-edge technique and Septal myectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 12 Mar 2020to 31 Jan 2022
- 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
- Provide written informed consent (either from the patient or a substitute decision-maker)
- Indications for surgical treatment (septal myectomy) of hypertrophic cardiomyopathy
Who cannot join
- indications for mitral valve replacement
- Patient failure at any stage of the study
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
"E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation
Novosibirsk
Alexander V. Bogachev-Prokophiev, MD, PhD, +73833476029, bogachev.prokophiev@gmail.com
Sergei Budagaev, 89021606921, ser.bud.med@gmail.com
About this study
Official title: A Randomised Controlled Pilot Trial: Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy
Objective of the study: to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.
Read the detailed description
A randomised controlled pilot trial to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic 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 septal myectomy + edge-to-edge mitral valve repair or isolated septal myectomy. All surgeons were experienced at least 50 related procedures.
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Being tested
- mitral valve repair by edge-to-edge technique, Septal myectomy
- Keywords
- edge-to-edge repair, mitral valve plastic (MVP), Septal myectomy
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitral valve repair by edge-to-edge techniqueProcedure or surgery
Also called Alfieri stitch
transaortic access for mitral valve repair edge-to-edge
Septal myectomyProcedure or surgery
Also called Septal myectomy (SM)
isolated extended septal myectomy
| Study group | Role | What they receive |
|---|---|---|
| isolated septal myectomy | Other | Isolated extended septal myectomy Receives: Procedure: Septal myectomy |
| Septal myectomy+ "edge-to-edge" | Active comparator | advanced septal myectomy in combination with mitral valve repair using the edge-to-edge technique Receives: Procedure: mitral valve repair by edge-to-edge technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Outflow Tract (LVOT) gradient
Gradient at the level of the output section of the left ventricle after surgery (mmHg) This measurement will be performed by transthoracic echocardiography at rest and / or during exercise. The Doppler method will be used.
Measured: 12 months in the medium-term follow-up
Secondary outcomes (1)
Systolic anterior motion of the mitral valve
Systolic anterior motion of the mitral valve after surgery This measurement will be performed by transthoracic echocardiography at rest and / or during exercise.
Measured: 12 months in the medium-term follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start12 Mar 2020
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Obstructive 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
- Model description
- A randomized clinical trial comparing mitral valve repair using the edge-to-edge technique for surgical treatment of hypertrophic cardiomyopathy
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Alexander V. Bogachev-Prokophiev, MD, PhD, Principal investigator, E.Meshalkin National medical research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470102
- Sponsor's protocol ID
- 188
- Acronym
- PRIZMA-pilot
- Status last verified
- Jul 2020
- First submitted
- 8 Jul 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Pilot Trial: Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04470102
- Acronym / sponsor ID
- PRIZMA-pilot / 188
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Keywords
- edge-to-edge repair, mitral valve plastic (MVP), Septal myectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 14 Jul 2020 (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 edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.
Detailed description
A randomised controlled pilot trial to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic 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 septal myectomy + edge-to-edge mitral valve repair or isolated septal myectomy. 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
- Model description
- A randomized clinical trial comparing mitral valve repair using the edge-to-edge technique for surgical treatment of hypertrophic cardiomyopathy
| Arm | Type | Receives |
|---|---|---|
| isolated septal myectomy | Other | Procedure: Septal myectomyIsolated extended septal myectomy |
| Septal myectomy+ "edge-to-edge" | Active comparator | Procedure: mitral valve repair by edge-to-edge techniqueadvanced septal myectomy in combination with mitral valve repair using the edge-to-edge technique |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Provide written informed consent (either from the patient or a substitute decision-maker)
- Indications for surgical treatment (septal myectomy) of hypertrophic cardiomyopathy
Key exclusion criteria (2 listed)
- indications for mitral valve replacement
- Patient failure at any stage of the study
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 repair by edge-to-edge techniqueAlso: Alfieri stitchtransaortic access for mitral valve repair edge-to-edge | Procedure or surgery | Septal myectomy+ "edge-to-edge" |
| Septal myectomyAlso: Septal myectomy (SM)isolated extended septal myectomy | Procedure or surgery | isolated septal myectomy |
Primary outcome
Left Ventricular Outflow Tract (LVOT) gradient
Time frame: 12 months in the medium-term follow-up
Gradient at the level of the output section of the left ventricle after surgery (mmHg) This measurement will be performed by transthoracic echocardiography at rest and / or during exercise. The Doppler method will be used.
1 secondary outcome
Systolic anterior motion of the mitral valve
Time frame: 12 months in the medium-term follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
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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.
Alexander V. Bogachev-Prokophiev, MD, PhD principal investigator
E.Meshalkin National medical research center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mitral valve repair by edge-to-edge technique and Septal myectomy in people with Hypertrophic Obstructive 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander V. Bogachev-Prokophiev, MD, PhD (+73833476029, bogachev.prokophiev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Outflow Tract (LVOT) gradient (time frame: 12 months in the medium-term follow-up). 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 21 Jul 2020.