MitraClip in Patients With Heart Failure

Study acronym: MitraClip
StatusUnknown
PhaseNot specified
Started

Record status This record was last updated October 9, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

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Record History

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Minor Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06633159
Lead Sponsor The League of Clinical Research, Russia
Collaborators: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Conditions
(from sponsor)
Mitral Regurgitation
Related terms Mitral Valve Insufficiency
Enrollment 196 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov