Clinical trial NCT06757049: Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population
Official title: Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population(THE KOREA MITRIS REGISTRY)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Valve Insufficiency
Keywords: Mitral Valve Replacement
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2025-01-03
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asian(REPUBLIC OF KOREA)

Brief summary: 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.

Eligibility 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:

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

Primary outcomes:
measure: Cardiovascular death
timeFrame: 1 year post-surgery
measure: Valve-related intervention
timeFrame: 1 year post-surgery
measure: Structural valve deterioration and non-structural valve dysfunction
timeFrame: 1 year post-surgery
Secondary outcomes:
measure: Peak and mean trans-mitral valve pressure gradient and effective orifice area
timeFrame: 6 month,1 year,2 year,3 year, 5year post-surgery
measure: All-cause death
timeFrame: 6 month,1 year,2 year,3 year, 5year post-surgery
measure: cardiovascular death
timeFrame: 6 month,1 year,2 year,3 year, 5year post-surgery
measure: Valve-related death
timeFrame: 6 month,1 year,2 year,3 year, 5year post-surgery
measure: Stroke (ischemic or hemorrhagic)
timeFrame: 6 month,1 year,2 year,3 year, 5year post-surgery
measure: Hospitalization due to cardiovascular disease
timeFrame: 6 month,1 year,2 year,3 year, 5year post-surgery
measure: Bleeding
timeFrame: 6 month,1 year,2 year,3 year, 5year post-surgery
measure: Infective endocarditis related to the mitral valve
timeFrame: 6 month,1 year,2 year,3 year, 5year post-surgery
measure: Valve-related reintervention
timeFrame: 6 month,1 year,2 year,3 year, 5year post-surgery
measure: Structural valve deterioration or non-structural valve dysfunction
timeFrame: 6 month,1 year,2 year,3 year, 5year post-surgery
measure: Valve thrombosis
timeFrame: 6 month,1 year,2 year,3 year, 5year post-surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: cadiovascularthoracic surgery
name: HOJIN KIM, PI
role: STUDY_CHAIR
References: