About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Asan Medical Center
Lead sponsor
Edwards Lifesciences
Collaborator