An observational study in Mitral Regurgitation, sponsored by University Hospital of Cologne. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University Hospital of Cologne · Observational
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.
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.
459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 154 across 167 observational studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →University Hospital of Cologne is the lead sponsor of 42 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair using the MitraClip fifth-generation (G5) system at participating centers.
Exclusion Criteria:
- None
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.
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.
Time frame: At hospital discharge (typically 1-5 days post-procedure)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days post-procedure (window)
No study locations are listed for this record.
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University Hospital of Cologne