MITRAClip GENeration 5 Mitral Valve Transcatheter Edge-to-Edge Repair Registry
ConditionMitral Regurgitation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital of Cologne
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older at the time of M-TEER
Treatment using the MitraClip G5 system
Disqualifiers
None
Trial population
Patients with mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair using the MitraClip fifth-generation (G5) system at participating centers.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
MitraClip G5
DeviceFifth-generation MitraClip system for mitral valve transcatheter edge-to-edge repair, used as part of routine clinical care. No study-specific interventions are performed.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: MitraClip G5 Cohort1 intervention
Trial outcomes
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.
Time frame
At hospital discharge (typically 1-5 days post-procedure)Secondary outcomes
1
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)2
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)3
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)4
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)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital of Cologne
Lead sponsor
Montefiore Medical Center
Collaborator
Cardiovascular Research Foundation, New York
Collaborator
Source ClinicalTrials.gov
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