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

Recruiting now

Conditions studied: Mitral Valve Insufficiency

In brief

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

Key facts

Study ID

NCT06757049

Run by

Asan Medical Center

People needed

200

Starts

2024-12-20

Expected to finish

2031-03-31

Last updated by the study team

2025-01-03

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Asan Medical Center — Seoul, SONGPA-GU, South Korea (enrolling)

Full record on ClinicalTrials.gov

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