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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Device: MitraClip G5

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Victor Mauri, MD; Email: victor.mauri@uk-koeln.de
• Study Contact Backup: Name: Philipp von Stein, MD; Phone Number: 646-321-8145; Email: philipp.von-stein@uk-koeln.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital of Cologne
• Collaborators: Montefiore Medical Center; Cardiovascular Research Foundation, New York
• Investigators: Principal Investigator: Azeem Latib, MD, Montefiore Medical Center; Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: MitraClip; M-TEER; Mitral Valve Transcatheter Edge-to-Edge Repair; MitraClip G5
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: MITRAGEN5-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymized data may be shared with collaborating investigators for pre-approved sub-studies on a case-by-case basis upon reasonable request to the principal investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No