RecruitingNCT06633159

MitraClip in Patients With Heart Failure

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


Sponsor

The League of Clinical Research, Russia

Enrollment

196 participants

Start Date

Apr 15, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting data on patients who have received a MitraClip procedure — a minimally invasive, catheter-based procedure to repair a leaky heart valve (mitral regurgitation) without open-heart surgery. The study tracks both new patients going forward and past patients to understand real-world outcomes of this procedure in people with heart failure. **You may be eligible if...** - You are 18 or older and have been recommended for or have already received the MitraClip G4 procedure for a leaky mitral heart valve - You are able to understand and sign consent for your personal data - (For past patients) Your procedure was performed on or after January 1, 2022 **You may NOT be eligible if...** - Your expected life expectancy is less than 12 months - You have a condition that prevents you from completing study visits (such as severe dementia or addiction) - You are currently in another clinical trial - (For past patients) Complete medical records are not available Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMitraClip

surgical intervention to correct mitral regurgitation by percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets


Locations(1)

League of Clinical Research (LeagueCRR)

Moscow, Russia

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NCT06633159


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