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

Asan Medical Center

Status: Enrolling

Conditions: Mitral Valve Insufficiency

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06757049

2024-1268

Details and patient eligibility

About

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

Full description

This study is a prospective, investigator-Investigator initiated, multicenter observational study that aims to competitively register 200 patients who have undergone mitral valve replacement surgery with the MITRIS RESILIA mitral valve at participating institutions to collect real clinical outcomes.

This study will collect data on clinical outcomes obtained during standard care for patients who undergo mitral valve replacement surgery using the MITRIS RESILIA mitral valve in South Korea.

The aim is to recruit 200 patients using the MITRIS RESILIA mitral valve (competitive recruitment, no more than 100 per institution) over a period of two years.

All patients registered in the registry will be followed for five years. Follow-up assessments will occur at 6 months, 1 year, 2 years, 3 years, and 5 years post-surgery. Including the 2-year registration period and 5 years of follow-up for result analysis, the total study duration is expected to be approximately 7.5 years. However, the overall duration may vary depending on the rate of participant registration.

Enrollment: 200 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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 <30 mL/min/1.73m²
4. Undergoing surgery for infective endocarditis