Actively Recruiting
MitraClip in Patients With Heart Failure
Led by The League of Clinical Research, Russia · Updated on 2024-10-09
196
Participants Needed
1
Research Sites
85 weeks
Total Duration
On this page
Sponsors
T
The League of Clinical Research, Russia
Lead Sponsor
N
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MitraClip in Patients With Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients indicated for mitral regurgitation correction surgery using MitraClip G4 implantation
- Age 18 years or older
- Able to understand and voluntarily sign informed consent
- Patients who have undergone mitral regurgitation correction with MitraClip G4 implantation (retrospective group)
- Surgery performed on or after January 1, 2022 (retrospective group)
You will not qualify if you...
- Expected life expectancy less than 12 months
- Other diseases limiting ability to attend study visits
- Conditions limiting compliance with study requirements such as dementia, psychoneurological diseases, drug addiction, or alcoholism
- Current participation in other clinical trials or prior participation in this trial
- Lack of access to complete primary medical documentation for retrospective patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
League of Clinical Research (LeagueCRR)
Moscow, Russia, 119590
Actively Recruiting
Research Team
O
Oleg Melikhov, MD
CONTACT
S
Svetlana Elkonina
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here