Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Mitral Valve Insufficiency. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population(THE KOREA MITRIS REGISTRY)
Overview
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
Detailed 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.
Primary outcome measures
- Cardiovascular death [Time frame: 1 year post-surgery]
- Valve-related intervention [Time frame: 1 year post-surgery]
- Structural valve deterioration and non-structural valve dysfunction [Time frame: 1 year post-surgery]
Secondary outcome measures (11)
- Peak and mean trans-mitral valve pressure gradient and effective orifice area [Time frame: 6 month,1 year,2 year,3 year, 5year post-surgery]
- All-cause death [Time frame: 6 month,1 year,2 year,3 year, 5year post-surgery]
- cardiovascular death [Time frame: 6 month,1 year,2 year,3 year, 5year post-surgery]
- Valve-related death [Time frame: 6 month,1 year,2 year,3 year, 5year post-surgery]
- Stroke (ischemic or hemorrhagic) [Time frame: 6 month,1 year,2 year,3 year, 5year post-surgery]
- Hospitalization due to cardiovascular disease [Time frame: 6 month,1 year,2 year,3 year, 5year post-surgery]
- Bleeding [Time frame: 6 month,1 year,2 year,3 year, 5year post-surgery]
- Infective endocarditis related to the mitral valve [Time frame: 6 month,1 year,2 year,3 year, 5year post-surgery]
- Valve-related reintervention [Time frame: 6 month,1 year,2 year,3 year, 5year post-surgery]
- Structural valve deterioration or non-structural valve dysfunction [Time frame: 6 month,1 year,2 year,3 year, 5year post-surgery]
- Valve thrombosis [Time frame: 6 month,1 year,2 year,3 year, 5year post-surgery]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
South Korea · 1 center
- Asan Medical Center — Seoul
Identifiers
NCT: NCT06757049 · 2024-1268