Mitral Valve Insufficiency, Mitral Regurgitation, Mitral Valve Regurgitation
Conditions
Keywords
MitraClip
Brief summary
This study is to evaluate the efficacy and safety of Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation
Interventions
DEVICEMitraClip
Transcatheter Mitral Valvuloplasty with MitraClip
Sponsors
CardioVascular Research Foundation, Korea
Duk-Woo Park, MD
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus \[degenerative MR\] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation. * Age 19 and more * Written informed consent
Exclusion criteria
* Patients who cannot tolerate procedural anticoagulation or post-procedural antiplatelet regimen * Active endocarditis of the mitral valve * Rheumatic mitral valve disease * Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mitral regurgitation | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke | 1 year | — |
| Myocardial infarction | 1 year | — |
| Re-hospitalization | 1 year | — |
| All cause death | 1 year | — |
| Vascular complication | 5 days | — |
| Bleeding | 5 days | — |
| Successful valvuloplasty | 5 days | No significant complication |
| Acute kidney dysfunction | 5 days | — |
Countries
South Korea
Outcome results
None listed