MITRAClip GENeration 5 Mitral Valve Transcatheter Edge-to-Edge Repair Registry

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07543874

Acronym

MITRAGEN5

Enrollment

1000

Registered

2026-04-22

Start date

2026-05-01

Completion date

2030-12-31

Last updated

2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation

Keywords

MitraClip, Mitral Valve Transcatheter Edge-to-Edge Repair, M-TEER, MitraClip G5

Brief summary

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.

Detailed 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.

Interventions

DEVICEMitraClip 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.

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

\- None

Design outcomes

Primary

Measure	Time frame	Description
Proportion of Patients with Residual Mitral Regurgitation ≤1+ at Discharge	At hospital discharge (typically 1-5 days post-procedure)	Proportion of patients with residual mitral regurgitation grade 1+ or less at hospital discharge, as assessed by transthoracic echocardiography.

Secondary

Measure	Time frame	Description
Change in NYHA Functional Class from Baseline to 30 Days	Baseline and 30 days post-procedure (window)	Change in New York Heart Association (NYHA) functional class from baseline to 30-day follow-up.
Rate of Major Adverse Events at 30 Days	30 days post-procedure (window)	Composite rate of major adverse events at 30 days, including death, stroke, device embolization, cardiac surgery for device-related complications, and need for reintervention.
Rate of All-Cause Mortality at 30 Days	30 days post-procedure (window)	Rate of death from any cause within 30 days of the index procedure.
Rate of Heart Failure Hospitalization at 30 Days	30 days post-procedure (window)	Rate of hospitalization for heart failure within 30 days of the index procedure.
Proportion of Patients with Residual MR ≤1+ at 30 Days	30 days post-procedure (window)	Proportion of patients maintaining residual mitral regurgitation grade 1+ or less at 30-day follow-up, as assessed by transthoracic echocardiography.

Contacts

CONTACTPhilipp von Stein, MD

philipp.von-stein@uk-koeln.de646-321-8145

CONTACTVictor Mauri, MD

victor.mauri@uk-koeln.de

PRINCIPAL_INVESTIGATORPhilipp von Stein, MD

University Hospital Cologne

PRINCIPAL_INVESTIGATORVictor Mauri, MD

University Hospital Cologne

PRINCIPAL_INVESTIGATORPier Pasquale Leone, MD, MSc

Montefiore Medical Center

PRINCIPAL_INVESTIGATORAzeem Latib, MD