Outcomes of Patients tReated wIth Mitral Transcatheter Edge-to-edge Repair for Primary Mitral Regurgitation Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Regurgitation
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Enrollment
- 2000
- Locations
- 6
- Primary Endpoint
- All-cause mortality
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •clinically significant primary mitral regurgitation
- •patient underwent M-TEER
- •echocardiography data at baseline, procedure and follow-up
- •follow-up of at least 12 months
- •Exclusion Criteria
- •age under 18 years
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
All-cause mortality
Time Frame: 12 months
Incidence of death from any cause.
Cardiovascular mortality
Time Frame: 12 months
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.
Rehospitalization for congestive heart failure
Time Frame: 12 months
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.
Re-do mitral valve procedure
Time Frame: 12 months
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.
Secondary Outcomes
- Residual mitral regurgitation(12 months)
- MVARC (Mitral Valve Academic Research Consortium) Technical success(1 day (at exit from the catheterization laboratory))
- Functional success(1 day (at exit from the catheterization laboratory))