The MITRAGEN5 Registry is an international, multicenter, observational registry thatcollects data on patients with mitral regurgitation who are treated with thefifth-generation MitraClip (G5) device. The MitraClip is a small device used to repairthe mitral valve of the heart without open-heart surgery, a procedure called mitral valvetranscatheter edge-to-edge repair (M-TEER). This registry aims to evaluate how safe andeffective the MitraClip G5 is in everyday clinical practice across multiple hospitalsworldwide. All procedures, tests, and follow-up visits are part of routine clinical care.No additional study-specific procedures are performed. Data are collected in anonymizedform from participating centers.
The MitraClip system is used for mitral valve transcatheter edge-to-edge repair, aimed at
treating mitral regurgitation. The fifth generation (G5) introduces iterative
enhancements to the delivery platform, including a redesigned steerable guide catheter,
updated stabilizer with a new guide attach feature, and refined attachment and securement
mechanisms. All these features are aimed at facilitating device handling, positioning,
and procedural efficiency. The MitraClip sizes and their fundamental design remain
unchanged from the fourth generation. This investigator-initiated registry aims to
collect comprehensive real-world data from international high-volume centers to
characterize the safety and effectiveness of the MitraClip G5 in a broad patient
population treated according to local clinical practice. Enrollment includes
retrospective data from patients treated since the introduction of the MitraClip G5 at
each center. Data collection includes baseline clinical and echocardiographic
characteristics, procedural details, in-hospital outcomes, and follow-up information
available from routine clinical care.
Device: MitraClip G5
Fifth-generation MitraClip system for mitral valve transcatheter edge-to-edge repair,
used as part of routine clinical care. No study-specific interventions are performed.
Inclusion Criteria:
- Age 18 years or older at the time of M-TEER
- Treatment using the MitraClip G5 system
Exclusion Criteria:
- None
Not Provided
Philipp von Stein, MD
646-321-8145
philipp.von-stein@uk-koeln.de
Victor Mauri, MD
victor.mauri@uk-koeln.de