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| Name | Class |
|---|---|
| National Medical Research Center for Cardiology, Ministry of Health of Russian Federation | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MitraClip | Device | surgical intervention to correct mitral regurgitation by percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 12 |
| Hospitalization for heart failure |
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Cohort 1 (prospective patients)
Inclusion Criteria:
Exclusion Criteria:
Cohort 2 (retrospective patients)
Inclusion Criteria:
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.
Exclusion Criteria:
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Adult patients aged 18 years and older with heart failure and implanted MitraClip G4 mitral valve clips.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oleg Melikhov, MD | Contact | +79166950530 | melikhov.oleg@gmail.com | |
| Svetlana Elkonina | Contact | +79164454877 | elkonina.svetlana@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sergey A Boytsov, Prof. | Research Institute of Cardiology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| League of Clinical Research (LeagueCRR) | Recruiting | Moscow | 119590 | Russia |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | Month 12 |
| Safety of surgical intervention: сardiac surgery | Cardiac surgery during the 12-month follow-up period | Month 12 |