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| Name | Class |
|---|---|
| Montefiore Medical Center | OTHER |
| Cardiovascular Research Foundation, New York | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- None
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Patients with mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair using the MitraClip fifth-generation (G5) system at participating centers.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philipp von Stein, MD | Contact | 646-321-8145 | philipp.von-stein@uk-koeln.de | |
| Victor Mauri, MD | Contact | victor.mauri@uk-koeln.de |
| Name | Affiliation | Role |
|---|---|---|
| Philipp von Stein, MD | University Hospital Cologne | Principal Investigator |
| Victor Mauri, MD | University Hospital Cologne | Principal Investigator |
| Pier Pasquale Leone, MD, MSc |
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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.
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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) |
| Montefiore Medical Center |
| Principal Investigator |
| Azeem Latib, MD | Montefiore Medical Center | Principal Investigator |