MITRAClip GENeration 5 Mitral Valve Transcatheter Edge-to-Edge Repair Registry (MITRAGEN5 Registry)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 1,000
- Primary Endpoint
- Residual Mitral Regurgitation at Discharge
Study Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older at the time of M-TEER
- •Treatment using the MitraClip G5 system
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: MitraClip G5 (Device)
Outcomes
Primary Outcomes
Residual Mitral Regurgitation 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.
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
- Functional Capacity (NYHA Class) at 30 Days(30 days post-procedure (window))
- Major Adverse Events at 30 Days(30 days post-procedure (window))
- All-Cause Mortality at 30 Days(30 days post-procedure (window))
- Heart Failure Hospitalization at 30 Days(30 days post-procedure (window))
- Durability of MR Reduction at 30 Days(30 days post-procedure (window))
- 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))
Investigators
Philipp von Stein
Principal Investigator, MITRAGEN5 Registry
University Hospital of Cologne