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).
Study Type
OBSERVATIONAL
Enrollment
2,000
Montefiore Medical Center
New York, New York, United States
RECRUITINGCentre Hospitalier de Bordeaux
Bordeaux, France
RECRUITINGUniversité Lille, Inserm, Centre Hospitalier Universitaire de Lille
Lille, France
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
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University Hospital of Rennes, Centre Hospitalier de Rennes
Rennes, France
RECRUITINGUniversity Heart & Vascular Center Hamburg
Hamburg, Germany
RECRUITINGKlinikum der Universität München
Munich, Germany
RECRUITINGTime 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)