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

NCT07543874 | Not Yet Recruiting

• 1 other identifier: MITRAGEN5-2025
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mitral Regurgitation

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Proportion of patients with residual mitral regurgitation grade 1+ or less at hospital discharge, as assessed by transthoracic echocardiography.

  At hospital discharge (typically 1-5 days post-procedure)

Secondary Outcomes (5)

• Change in NYHA Functional Class from Baseline to 30 Days

  Baseline and 30 days post-procedure (window)

• Rate of Major Adverse Events at 30 Days

  30 days post-procedure (window)

• Rate of All-Cause Mortality at 30 Days

  30 days post-procedure (window)

• Rate of Heart Failure Hospitalization at 30 Days

  30 days post-procedure (window)

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

  30 days post-procedure (window)

Study Arms (1)

MitraClip G5 Cohort

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

Device: MitraClip G5

Interventions

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.

MitraClip G5 Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair using the MitraClip fifth-generation (G5) system at participating centers.

You may qualify if:

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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Cardiovascular Research Foundation, New York: collaborator
• University Hospital of Cologne: lead
• Montefiore Medical Center: collaborator

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Philipp von Stein, MD

  University Hospital Cologne

  PRINCIPAL INVESTIGATOR

• Victor Mauri, MD

  University Hospital Cologne

  PRINCIPAL INVESTIGATOR

• Pier Pasquale Leone, MD, MSc

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

• Azeem Latib, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philipp von Stein, MD

CONTACT

646-321-8145; philipp.von-stein@uk-koeln.de

Victor Mauri, MD

CONTACT

victor.mauri@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MITRAGEN5 Registry

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share