MitraClip in Patients With Heart Failure

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.

Eligibility

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.

Exclusion Criteria:

1. 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.
2. The surgery must have been performed no earlier than January 1, 2022.
3. Age 18 years and older.

Conditions2

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