Register of Patients With Heart Failure Who Underwent Surgery to Correct Mitral Regurgitation by Percutaneous Catheter Implantation of MitraClip on the Mitral Valve.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

• 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.

Locations
Other Locations
Russian Federation
League of Clinical Research (LeagueCRR)
RECRUITING
Moscow
Contact Information
Primary
Oleg Melikhov, MD
melikhov.oleg@gmail.com
+79166950530
Backup
Svetlana Elkonina
elkonina.svetlana@gmail.com
+79164454877
Time Frame
Start Date: 2024-04-15
Estimated Completion Date: 2025-12
Participants
Target number of participants: 196
Treatments
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.
Sponsors
Collaborators: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Leads: The League of Clinical Research, Russia

This content was sourced from clinicaltrials.gov