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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorAsan Medical Center

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

No trial groups listed

Sponsors and collaborators

Asan Medical Center

Lead sponsor

Edwards Lifesciences

Collaborator