MITRAClip GENeration 5 Mitral Valve Transcatheter Edge-to-Edge Repair Registry (MITRAGEN5)

University Hospital of Cologne

Status: Not yet enrolling

Conditions: Mitral Regurgitation

Treatments: Device: MitraClip G5

Study type: Observational

Funder types: Other

Identifiers

NCT07543874

MITRAGEN5-2025

Details and patient eligibility

About

The MITRAGEN5 Registry is an international, multicenter, observational registry that collects data on patients with mitral regurgitation who are treated with the fifth-generation MitraClip (G5) device. The MitraClip is a small device used to repair the mitral valve of the heart without open-heart surgery, a procedure called mitral valve transcatheter edge-to-edge repair (M-TEER). This registry aims to evaluate how safe and effective the MitraClip G5 is in everyday clinical practice across multiple hospitals worldwide. All procedures, tests, and follow-up visits are part of routine clinical care. No additional study-specific procedures are performed. Data are collected in anonymized form from participating centers.

Full description

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older at the time of M-TEER
• Treatment using the MitraClip G5 system

Exclusion criteria

- None

Trial design

1,000 participants in 1 patient group

MitraClip G5 Cohort

Description:

All patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER) using the MitraClip fifth-generation (G5) system at participating centers.

Treatment:

Device: MitraClip G5