Mitral RegurgitationMitraClipNCT06633159
MitraClip in Patients With Heart Failure
An observational study of Mitral Regurgitation, run by The League of Clinical Research, Russia at 1 site in Russia.
Trial summary
Multicenter observational study. The study does not involve any interventions in routine clinical practice, the choice of treatment method (including the type of medical device used and the method of surgical intervention) and the methods of examination and postoperative management of patients will not differ from the… 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?
- MitraClip
- Type of treatment
- Medical device
- How many people
- 196 participants
- Where
- 1 siteRussia
- Study dates
- 15 Apr 2024to Dec 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: Adult patients aged 18 years and older with heart failure and implanted MitraClip G4 mitral valve clips.
Who may be able to join
- Patients who are indicated for cardiac surgery to correct mitral regurgitation using transcatheter edge-to-edge reconstruction of the mitral valve by implanting the MitraClip G4 on the cusps of the mitral valve.
- Age 18 years and older.
- Understanding and voluntarily signing the informed consent form for the processing of personal data.
- 1.Patients who underwent cardiac surgery to correct mitral regurgitation using transcatheter edge-to-edge mitral valve reconstruction with MitraClip G4 clip implantation on the mitral valve leaflets.
Who cannot join
- The expected life expectancy of the patient is less than 12 months (contraindication to surgical intervention).
- The presence of concomitant diseases that limit the patient's ability to carry out visits according to the study protocol.
- Conditions that limit the patient's ability to comply with the study requirements (dementia, psychoneurological diseases, drug addiction, alcoholism, etc.).
- Simultaneous participation in other clinical trials or previous participation in this trial.
- Cohort 2 (retrospective patients)
- Patients for whom the physician-researcher cannot access primary medical documentation (medical records, outpatient cards) to collect complete and reliable information about the patient in the volume required by the study protocol.
- The surgery must have been performed no earlier than January 1, 2022.
- Age 18 years and older.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
League of Clinical Research (LeagueCRR)
Moscow, 119590
Oleg G Melikhov, MD, PhD, 0079166950530, melikhov.oleg@gmail.com
Svetlana I Elkonina, MD, 0079164454877, elkonina.svetlana@gmail.com
About this study
Official title: Register of Patients With Heart Failure Who Underwent Surgery to Correct Mitral Regurgitation by Percutaneous Catheter Implantation of MitraClip on the Mitral Valve.
Multicenter observational study. The study does not involve any interventions in routine clinical practice, the choice of treatment method (including the type of medical device used and the method of surgical intervention) and the methods of examination and postoperative management of patients will not differ from the standard of care for patients requiring percutaneous transcatheter edge-to-edge mitral valve reconstruction by implantation of the MitraClip clip on the mitral valve leaflets, used in the daily medical practice of a medical institution. All medical devices under study (delivery device with the MitraClip clip on the mitral valve leaflets) are registered in the territory of the Russian Federation and are used in the conditions of routine medical practice. The study will include patients who have undergone surgical intervention to correct mitral regurgitation by percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets. It is expected to include at least 196 patients (at least 98 prospective patients and at least 98 retrospective patients). The planned number of research centers is 11 outpatient clinics, presumably in 6 regions of the Russian Federation.
Read the detailed description
Mitral regurgitation (MR) may result from either degenerative lesions of the mitral valve (MV) leaflets - degenerative MR (DMR) - or pathological dilation of the left ventricle (LV) - functional MR (FMR). In DMR, the MV apparatus itself is compromised by affected leaflets, chords, etc. In contrast, FMR is usually associated with cardiomyopathy (usually of ischemic etiology), with this type of MR being secondary to LV dysfunction. In both cases, there is a violation of leaflet co-optation and reverse blood flow from the LV into the left atrium. According to existing guidelines, surgical reconstruction (plastic surgery) is the preferred treatment option for DMR. Indications for invasive treatment of FMR are not so clear-cut due to the high rate of postoperative MR recurrence and the lack of reliable evidence of a positive effect of FMR correction on long-term survival. The greatest complexity is presented by the group of patients with severe MR and high or unacceptable surgical risk of open surgery.
For the treatment of severe MR in such patients, the method of transcatheter MV repair was proposed, which is an endovascular analogue of the suture "edge-to-edge" repair according to Alfieri. MitraClip system is approved in the European Union, the USA, the Middle East and the CIS (Kazakhstan, Belarus) for the treatment of high surgical risk patients with DMR and FMR with symptomatic heart failure of II-IV functional class according to the classification of the New York Heart Association (NYHA), persisting despite optimal drug therapy.
The aim of this study is to evaluate the safety and effectiveness of the procedure of percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets in a population of patients from the Russian Federation for the treatment of mitral regurgitation. Information on the health status of patients who have undergone the procedure of percutaneous transcatheter edge-to-edge mitral valve reconstruction by implanting the MitraClip clip on the mitral valve leaflets will be of high scientific and practical interest.
- Conditions
- Mitral Regurgitation
- Being tested
- MitraClip
- Keywords
- Clip implantation, Transcatheter plastic surgery, Mitral valve (MV), MitraClip, Mitral regurgitation (MR)
- 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.
MitraClipDevice
surgical intervention to correct mitral regurgitation by percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets
| Study group | Role | What they receive |
|---|---|---|
| prospective | The prospective part of the study will include patients who have undergone hospitalization for the purpose of surgical intervention to correct mitral regurgitation by percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets. Receives: Device: MitraClip | |
| retrospective | The retrospective part of the study will include patients who underwent surgical intervention to correct mitral regurgitation by percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets. Receives: Device: MitraClip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular mortality
To evaluate cardiovascular mortality within 12 months in patients with heart failure after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.
Measured: Month 12
Secondary outcomes (12)
All-cause mortality
To assess all-cause mortality within 12 months after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.
Measured: Month 12
Hospitalization for heart failure
To assess the incidence of hospitalization for heart failure within 12 months after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.
Measured: Month 12
Hospitalization for any cause
To assess the incidence of hospitalization for any cause within 12 months after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.
Measured: Month 12
Emergency surgical interventions
To assess the frequency of unplanned (emergency) surgical interventions on the mitral valve within 12 months after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.
Measured: Month 12
Functional class of heart failure
To assess the change in the functional class of heart failure within 12 months after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.
Measured: Month 1 - Month 3 - Month 12
N-terminal pre-brain natriuretic peptide
To assess the change in the level of N-terminal pre-brain natriuretic peptide over 12 months after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.
Measured: Month 1 - Month 12
Echocardiographic examination: severity of mitral regurgitation: I-IV;
To evaluate the change in echocardiographic examination parameters within 12 months after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.
Measured: Month 1 - Month 12
Echocardiographic examination:presence of severe mitral valve stenosis ;
To evaluate the change in echocardiographic examination parameters: presence of severe mitral valve stenosis within 12 months after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.
Measured: Month 1 - Month 12
Surgical complications
To assess the incidence of surgical complications within 12 months after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.
Measured: Month 12
Safety of surgical intervention
Surgical complications after correction of mitral regurgitation: yes/no. If yes: date of development of the complication, description of the complication (ICD-10 term), outcome of the complication at the 12-month follow-up period (death, resolved without consequences, resolved with consequences, ongoing).
Measured: Month 12
Safety of surgical intervention:AE
Adverse events: yes/no If yes: date of development of the AE, description of the AE (ICD-10 term), outcome of the AE by the 12-month follow-up period (death, resolved without consequences, resolved with consequences, ongoing).
Measured: Month 12
Safety of surgical intervention: сardiac surgery
Cardiac surgery during the 12-month follow-up period
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start15 Apr 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 196 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- The League of Clinical Research, Russia
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- Responsible party
- Sponsor
- Investigators
- Sergey A Boytsov, Prof., Study chair, Research Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633159
- Sponsor's protocol ID
- СН-01-2023
- Acronym
- MitraClip
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Register of Patients With Heart Failure Who Underwent Surgery to Correct Mitral Regurgitation by Percutaneous Catheter Implantation of MitraClip on the Mitral Valve.
- ClinicalTrials.gov ID
- NCT06633159
- Acronym / sponsor ID
- MitraClip / СН-01-2023
- Conditions
- Mitral Regurgitation
- Keywords
- Clip implantation, Transcatheter plastic surgery, Mitral valve (MV), MitraClip, Mitral regurgitation (MR)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- The League of Clinical Research, RussiaUniversity, hospital or other
- Collaborators
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Oct 2024 (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.
Multicenter observational study. The study does not involve any interventions in routine clinical practice, the choice of treatment method (including the type of medical device used and the method of surgical intervention) and the methods of examination and postoperative management of patients will not differ from the standard of care for patients requiring percutaneous transcatheter edge-to-edge mitral valve reconstruction by implantation of the MitraClip clip on the mitral valve leaflets, used in the daily medical practice of a medical institution. All medical devices under study (delivery device with the MitraClip clip on the mitral valve leaflets) are registered in the territory of the Russian Federation and are used in the conditions of routine medical practice. The study will include patients who have undergone surgical intervention to correct mitral regurgitation by percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets. It is expected to include at least 196 patients (at least 98 prospective patients and at least 98 retrospective patients). The planned number of research centers is 11 outpatient clinics, presumably in 6 regions of the Russian Federation.
Detailed description
Mitral regurgitation (MR) may result from either degenerative lesions of the mitral valve (MV) leaflets - degenerative MR (DMR) - or pathological dilation of the left ventricle (LV) - functional MR (FMR). In DMR, the MV apparatus itself is compromised by affected leaflets, chords, etc. In contrast, FMR is usually associated with cardiomyopathy (usually of ischemic etiology), with this type of MR being secondary to LV dysfunction. In both cases, there is a violation of leaflet co-optation and reverse blood flow from the LV into the left atrium. According to existing guidelines, surgical reconstruction (plastic surgery) is the preferred treatment option for DMR. Indications for invasive treatment of FMR are not so clear-cut due to the high rate of postoperative MR recurrence and the lack of reliable evidence of a positive effect of FMR correction on long-term survival. The greatest complexity is presented by the group of patients with severe MR and high or unacceptable surgical risk of open surgery.
For the treatment of severe MR in such patients, the method of transcatheter MV repair was proposed, which is an endovascular analogue of the suture "edge-to-edge" repair according to Alfieri. MitraClip system is approved in the European Union, the USA, the Middle East and the CIS (Kazakhstan, Belarus) for the treatment of high surgical risk patients with DMR and FMR with symptomatic heart failure of II-IV functional class according to the classification of the New York Heart Association (NYHA), persisting despite optimal drug therapy.
The aim of this study is to evaluate the safety and effectiveness of the procedure of percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets in a population of patients from the Russian Federation for the treatment of mitral regurgitation. Information on the health status of patients who have undergone the procedure of percutaneous transcatheter edge-to-edge mitral valve reconstruction by implanting the MitraClip clip on the mitral valve leaflets will be of high scientific and practical interest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prospective | – | Device: MitraClipThe prospective part of the study will include patients who have undergone hospitalization for the purpose of surgical intervention to correct mitral regurgitation by percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets. |
| retrospective | – | Device: MitraClipThe retrospective part of the study will include patients who underwent surgical intervention to correct mitral regurgitation by percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 years and older with heart failure and implanted MitraClip G4 mitral valve clips.
Key inclusion criteria (4 listed)
- Patients who are indicated for cardiac surgery to correct mitral regurgitation using transcatheter edge-to-edge reconstruction of the mitral valve by implanting the MitraClip G4 on the cusps of the mitral valve.
- Age 18 years and older.
- Understanding and voluntarily signing the informed consent form for the processing of personal data.
- 1.Patients who underwent cardiac surgery to correct mitral regurgitation using transcatheter edge-to-edge mitral valve reconstruction with MitraClip G4 clip implantation on the mitral valve leaflets.
Key exclusion criteria (8 listed)
- The expected life expectancy of the patient is less than 12 months (contraindication to surgical intervention).
- The presence of concomitant diseases that limit the patient's ability to carry out visits according to the study protocol.
- Conditions that limit the patient's ability to comply with the study requirements (dementia, psychoneurological diseases, drug addiction, alcoholism, etc.).
- Simultaneous participation in other clinical trials or previous participation in this trial.
- Cohort 2 (retrospective patients)
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 |
|---|---|---|
| MitraClipsurgical intervention to correct mitral regurgitation by percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets | Device | prospective, retrospective |
Primary outcome
Cardiovascular mortality
Time frame: Month 12
To evaluate cardiovascular mortality within 12 months in patients with heart failure after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.
12 secondary outcomes
All-cause mortality
Time frame: Month 12
Hospitalization for heart failure
Time frame: Month 12
Hospitalization for any cause
Time frame: Month 12
Emergency surgical interventions
Time frame: Month 12
Functional class of heart failure
Time frame: Month 1 - Month 3 - Month 12
N-terminal pre-brain natriuretic peptide
Time frame: Month 1 - Month 12
Echocardiographic examination: severity of mitral regurgitation: I-IV;
Time frame: Month 1 - Month 12
Echocardiographic examination:presence of severe mitral valve stenosis ;
Time frame: Month 1 - Month 12
Surgical complications
Time frame: Month 12
Safety of surgical intervention
Time frame: Month 12
Safety of surgical intervention:AE
Time frame: Month 12
Safety of surgical intervention: сardiac surgery
Time frame: Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Sergey A Boytsov, Prof. study chair
Research Institute of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation, run by The League of Clinical Research, Russia 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 4 inclusion and 8 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 9 Oct 2024. 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 Oleg Melikhov, MD (+79166950530, melikhov.oleg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular mortality (time frame: Month 12). 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 9 Oct 2024.