Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population
KOREA MITRIS
1 other identifier
observational
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2024
CompletedFirst Submitted
Initial submission to the registry
December 26, 2024
CompletedFirst Posted
Study publicly available on registry
January 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2031
January 3, 2025
December 1, 2024
6.3 years
December 26, 2024
December 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Cardiovascular death
death that results from a disease of the heart or blood vessels
1 year post-surgery
Valve-related intervention
a procedure to repair or replace a diseased or faulty heart valve
1 year post-surgery
Structural valve deterioration and non-structural valve dysfunction
abnormality that's not intrinsic to the valve
1 year post-surgery
Secondary Outcomes (11)
Peak and mean trans-mitral valve pressure gradient and effective orifice area
6 month,1 year,2 year,3 year, 5year post-surgery
All-cause death
6 month,1 year,2 year,3 year, 5year post-surgery
cardiovascular death
6 month,1 year,2 year,3 year, 5year post-surgery
Valve-related death
6 month,1 year,2 year,3 year, 5year post-surgery
Stroke (ischemic or hemorrhagic)
6 month,1 year,2 year,3 year, 5year post-surgery
- +6 more secondary outcomes
Eligibility Criteria
Asian(REPUBLIC OF KOREA)
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asan Medical Centerlead
- Edwards Lifesciencescollaborator
Study Sites (1)
Asan Medical Center
Seoul, SONGPA-GU, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
HOJIN KIM, PI
cadiovascularthoracic surgery
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 60 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 26, 2024
First Posted
January 3, 2025
Study Start
December 20, 2024
Primary Completion (Estimated)
March 31, 2031
Study Completion (Estimated)
March 31, 2031
Last Updated
January 3, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share