Outcomes of Patients tReated wIth Mitral Transcatheter Edge-to-edge Repair for Primary Mitral Regurgitation Registry

Study Overview
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Brief Summary
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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).

Official Title
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Outcomes of Patients tReated wIth Mitral Transcatheter Edge-to-edge Repair for Primary Mitral Regurgitation Registry

Conditions
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Mitral Regurgitation

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| M-TEER<br>Patients with primary mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Incidence of death from any cause. | 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. | 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. | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual mitral regurgitation | Mitral regurgitation severity (0, 1+, 2+, 3+, 4+) as assessed by transthoracic echocardiography at discharge. | 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. | 12 months | 
| MVARC (Mitral Valve Academic Research Consortium) Technical success | All of the following must be present: Absence of procedural mortality Successful access, delivery, and retrieval Successful deployment and correct positioning of the first device Freedom from emergency surgery or reintervention related to the device or access procedure | 1 day (at exit from the catheterization laboratory) | 
| Functional success | If one of the following is present: Residual mitral regurgitation ≤2+ Effective regurgitant orifice area ≤15 mm2 Transmitral gradient <5 mmHg | 1 day (at exit from the catheterization laboratory) |