An observational study in Mitral Regurgitation, sponsored by Universitätsklinikum Hamburg-Eppendorf. Recruiting at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-18.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational
This multinational, non-interventional, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent mitral valve transcatheter edge-to-edge repair (M-TEER) for primary mitral regurgitation (PMR).
459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 154 across 167 observational studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients undergoing transcatheter edge-to-edge repair for primary mitral regurgitation
Exclusion Criteria
Patients with primary mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair.
All-cause mortality
Incidence of death from any cause.
Time frame: 12 months
Cardiovascular mortality
Incidence of cardiovascular death, defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident.
Time frame: 12 months
Rehospitalization for congestive heart failure
Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization, e.g. as assessed by patient interviews or medical records.
Time frame: 12 months
Re-do mitral valve procedure
Incidence of unplanned surgical (mitral valve repair or replacement) or transcatheter re-intervention (re-do transcatheter edge-to-edge repair), e.g. as assessed by patient interviews or medical records.
Time frame: 12 months
Residual mitral regurgitation
Mitral regurgitation severity (0, 1+, 2+, 3+, 4+) as assessed by transthoracic echocardiography at discharge.
Time frame: up to 30 days
Residual mitral regurgitation
Mitral regurgitation severity (0, 1+, 2+, 3+, 4+) as assessed by transthoracic echocardiography at 1-year follow-up.
Time frame: 12 months
MVARC (Mitral Valve Academic Research Consortium) Technical success
All of the following must be present: 1. Absence of procedural mortality 2. Successful access, delivery, and retrieval 3. Successful deployment and correct positioning of the first device 4. Freedom from emergency surgery or reintervention related to the device or access procedure
Time frame: 1 day (at exit from the catheterization laboratory)
Functional success
If one of the following is present: 1. Residual mitral regurgitation ≤2+ 2. Effective regurgitant orifice area ≤15 mm2 3. Transmitral gradient \<5 mmHg
Time frame: 1 day (at exit from the catheterization laboratory)
Plan to share: No
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Universitätsklinikum Hamburg-Eppendorf