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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0011560
Enrollment
200
Registered
2026-02-02
Start date
2024-12-26
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Cardiovascular death ;Valve-related intervention ;Structural valve deterioration and non-structural valve dysfunction

Secondary

MeasureTime frame
structural valve deterioration or non-structural valve dysfunction;valve thrombosis;Peak and mean trans-mitral valve pressure gradient and effective orifice area ;All-cause death ;cardiovascular death;Valve-related death;ischemic or hemorrhagic stroke;Hospitalization due to causes related to cardiovascular disease;Bleeding ;Infective endocarditis of the mitral valve;valve-related reintervention

Countries

Korea, Republic of

Contacts

Public ContactHONGBI LEE

Asan Medical Center

hongbi725@amc.seoul.kr+82-2-2045-4348

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jul 23, 2026