The purpose of this study is to evaluate the early and mid-term safety and performance of the MITRIS RESILIA mitral valve in Asian patients in a real-world setting
Age 19 or older
Requires mitral valve replacement due to mitral valve dysfunction
The participant or their guardian can provide a written consent form approved by the IRB and agree to the research protocol and clinical follow-up schedule.
Life expectancy of less than one year due to causes other than cardiovascular disease
High-risk candidates for mitral valve replacement: Society of Thoracic Surgeons Predicted Risk of Mortality 10% or greater; EuroSCORE 10% or greater; estimated surgical mortality rate by the surgeon 10% or greater
Chronic kidney disease: eGFR <30 mL/min/1.73m²
Undergoing surgery for infective endocarditis
Asian(REPUBLIC OF KOREA)
Case-only
Prospective
Not listed
Cardiovascular death
death that results from a disease of the heart or blood vessels
Valve-related intervention
a procedure to repair or replace a diseased or faulty heart valve
Structural valve deterioration and non-structural valve dysfunction
abnormality that's not intrinsic to the valve
Peak and mean trans-mitral valve pressure gradient and effective orifice area
echocardiographic parameters used to assess mitral valve disease
All-cause death
the total number of deaths from any cause in a given population over a specific period of time
cardiovascular death
a death that results from a disease of the heart or blood vessels
Valve-related death
any death that is caused by Structural valve deterioration,Nonstructural dysfunction,Valve thrombosis,Embolism,Bleeding event,Operated valve endocarditis,Death related to reintervention on the operated valve
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Asan Medical Center
Lead sponsor
Edwards Lifesciences
Collaborator
