Mitral Regurgitation
Conditions
Keywords
Clip implantation, Transcatheter plastic surgery, Mitral valve (MV), MitraClip, Mitral regurgitation (MR)
Brief 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 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.
Interventions
DEVICEMitraClip
surgical intervention to correct mitral regurgitation by percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets
Sponsors
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
The League of Clinical Research, Russia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Cohort 1 (prospective patients) Inclusion Criteria: 1. 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. 2. Age 18 years and older. 3. Understanding and voluntarily signing the informed consent form for the processing of personal data.
Exclusion criteria
1. The expected life expectancy of the patient is less than 12 months (contraindication to surgical intervention). 2. The presence of concomitant diseases that limit the patient's ability to carry out visits according to the study protocol. 3. Conditions that limit the patient's ability to comply with the study requirements (dementia, psychoneurological diseases, drug addiction, alcoholism, etc.). 4. Simultaneous participation in other clinical trials or previous participation in this trial. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular mortality | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization for heart failure | Month 12 | 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. |
| Hospitalization for any cause | Month 12 | 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. |
| Emergency surgical interventions | Month 12 | 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. |
| Functional class of heart failure | Month 1 - Month 3 - Month 12 | 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. |
| N-terminal pre-brain natriuretic peptide | Month 1 - Month 12 | 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. |
| All-cause mortality | Month 12 | 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. |
| Echocardiographic examination:presence of severe mitral valve stenosis ; | Month 1 - Month 12 | 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. |
| Surgical complications | Month 12 | 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. |
| Safety of surgical intervention | Month 12 | 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). |
| Safety of surgical intervention:AE | Month 12 | 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). |
| Safety of surgical intervention: сardiac surgery | Month 12 | Cardiac surgery during the 12-month follow-up period |
| Echocardiographic examination: severity of mitral regurgitation: I-IV; | Month 1 - Month 12 | 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. |
Countries
Russia
Contacts
Primary ContactOleg Melikhov, MD
Backup ContactSvetlana Elkonina
Outcome results
None listed