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

Conditions: Mitral Valve Insufficiency

Sex: All

Ages: 19 Years – N/A

Healthy volunteers: No

Enrollment: 200

Sponsor: Asan Medical Center

Location: Asan Medical Center Seoul SONGPA-GU

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 Criteria

Inclusion Criteria: 1. Age 19 or older 2. Requires mitral valve replacement due to mitral valve dysfunction 3. 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 Criteria: 1. Life expectancy of less than one year due to causes other than cardiovascular disease 2. 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 3. Chronic kidney disease: eGFR \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06757049). StuddyBuddy aggregates publicly available trial information.