RecruitingNCT06757049

Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population

Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population(THE KOREA MITRIS REGISTRY)

Sponsor

Asan Medical Center

Enrollment

200 participants

Start Date

Dec 20, 2024

Study Type

OBSERVATIONAL

Conditions

Mitral Valve Insufficiency

Summary

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

Eligibility

Min Age: 19 Years

Inclusion Criteria3

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.

Exclusion Criteria4

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

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