CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

Study Overview
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Brief Summary
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This multinational, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent transcatheter mitral valve implantation (TMVI), in comparison to those screened for TMVI but deemed ineligible, who subsequently underwent interventional mitral valve edge-to-edge repair, mitral valve surgery or medical/conservative therapy.

Official Title
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Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry

Conditions
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Mitral Regurgitation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinically significant mitral insufficiency patient underwent screening for TMVI echocardiography data at baseline (and after TMVI, E2E and surgery) follow-up of at least 30 days 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 |
| --- | --- |
| Transcatheter Mitral Valve Implantation (TMVI)<br>Patients with successful TMVI screening, who underwent Transcatheter Mitral Valve Implantation subsequently. All devices may be included. | |
| Interventional mitral valve edge-to-edge repair (E2E)<br>Patients with TMVI screening failure, who subsequently underwent interventional mitral valve edge-to-edge repair. | |
| Mitral valve surgery (Surgery)<br>Patients with TMVI screening failure, who subsequently underwent mitral valve surgery (i.e., mitral valve repair or replacement). | |
| Medical therapy (OMT)<br>Patients with TMVI screening failure, who subsequently underwent conservative or optimal medical therapy (OMT). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mitral insufficiency grade 2+ or more | Mitral insufficiency measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. | 12 months | 
| Freedom from device-related complications |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined all-cause mortality or rehospitalization for congestive heart failure |  | 12 months | 
| All-cause mortality |  | 12 months | 
| Cardiovascular mortality |  | 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. | 12 months | 
| Combined cardiovascular mortality or rehospitalization for congestive heart failure |  | 12 months | 
| Unplanned mitral valve intervention | Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or left ventricular assist device implantation, e.g. as assessed by patient interviews. | 12 months | 
| Combined all-cause mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention |  | 12 months | 
| Combined cardiovascular mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention |  | 12 months | 
| New York Heart Association (NYHA) stage III or IV | Assessment of New York Heart Association (NYHA) classification stage (in- or outpatient) after 12 months follow-up, as assessed by patient interviews. | 12 months |