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NCT Number: NCT07543874

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

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.

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

MitraClip G5

Device

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.

Primary outcomes

  1. Proportion of Patients with Residual Mitral Regurgitation ≤1+ at Discharge

    Time frame: 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 outcomes

  1. Change in NYHA Functional Class from Baseline to 30 Days

    Time frame: Baseline and 30 days post-procedure (window)

    Change in New York Heart Association (NYHA) functional class from baseline to 30-day follow-up.

  2. Rate of Major Adverse Events at 30 Days

    Time frame: 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.

  3. Rate of All-Cause Mortality at 30 Days

    Time frame: 30 days post-procedure (window)

    Rate of death from any cause within 30 days of the index procedure.

  4. Rate of Heart Failure Hospitalization at 30 Days

    Time frame: 30 days post-procedure (window)

    Rate of hospitalization for heart failure within 30 days of the index procedure.

  5. Proportion of Patients with Residual MR ≤1+ at 30 Days

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Philipp von Stein, MD

CONTACT

[email protected]

646-321-8145

Victor Mauri, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital of Cologne

Other

Collaborators

  • Cardiovascular Research Foundation, New York
  • Montefiore Medical Center

Registry information

Official study title

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

Acronym: MITRAGEN5

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Apr 22, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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