Mitral Valve InsufficiencyKOREA MITRISNCT06757049
Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population
An observational study of Mitral Valve Insufficiency, run by Asan Medical Center at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Mitral Valve Insufficiency
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Dec 2024to 31 Mar 2031
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asian(REPUBLIC OF KOREA)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, SONGPA-GU
HOJIN KIM, PI, 82-2-3010-0506
About this study
Official title: Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population(THE KOREA MITRIS REGISTRY)
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
Read the 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.
- Conditions
- Mitral Valve Insufficiency
- Keywords
- Mitral Valve Replacement
- Medical subject headings
- Mitral Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular death
death that results from a disease of the heart or blood vessels
Measured: 1 year post-surgery
Valve-related intervention
a procedure to repair or replace a diseased or faulty heart valve
Measured: 1 year post-surgery
Structural valve deterioration and non-structural valve dysfunction
abnormality that's not intrinsic to the valve
Measured: 1 year post-surgery
Secondary outcomes (11)
Peak and mean trans-mitral valve pressure gradient and effective orifice area
echocardiographic parameters used to assess mitral valve disease
Measured: 6 month,1 year,2 year,3 year, 5year post-surgery
All-cause death
the total number of deaths from any cause in a given population over a specific period of time
Measured: 6 month,1 year,2 year,3 year, 5year post-surgery
cardiovascular death
a death that results from a disease of the heart or blood vessels
Measured: 6 month,1 year,2 year,3 year, 5year post-surgery
Valve-related death
any death that is caused by Structural valve deterioration,Nonstructural dysfunction,Valve thrombosis,Embolism,Bleeding event,Operated valve endocarditis,Death related to reintervention on the operated valve
Measured: 6 month,1 year,2 year,3 year, 5year post-surgery
Stroke (ischemic or hemorrhagic)
a medical emergency that occurs when blood flow to the brain is blocked or a blood vessel in the brain bursts
Measured: 6 month,1 year,2 year,3 year, 5year post-surgery
Hospitalization due to cardiovascular disease
a hospital admission with a defined cardiovascular cause
Measured: 6 month,1 year,2 year,3 year, 5year post-surgery
Bleeding
BARC classification use.(A standardized tool for defining and categorizing bleeding events in clinical trials.)
Measured: 6 month,1 year,2 year,3 year, 5year post-surgery
Infective endocarditis related to the mitral valve
a bacterial, viral, or fungal infection of the mitral valve leaflets
Measured: 6 month,1 year,2 year,3 year, 5year post-surgery
Valve-related reintervention
any invasive procedure performed on the aortic valve, coronary button, or proximal aorta
Measured: 6 month,1 year,2 year,3 year, 5year post-surgery
Structural valve deterioration or non-structural valve dysfunction
a type of valve dysfunction that involves permanent damage to the valve
Measured: 6 month,1 year,2 year,3 year, 5year post-surgery
Valve thrombosis
a rare but life-threatening condition that occurs when a thrombus forms on a prosthetic heart valve and interferes with blood flow or valve function
Measured: 6 month,1 year,2 year,3 year, 5year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start20 Dec 2024
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, HO JIN KIM, Asan Medical Center
- Investigators
- HOJIN KIM, PI, Study chair, cadiovascularthoracic surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757049
- Sponsor's protocol ID
- 2024-1268
- Acronym
- KOREA MITRIS
- Status last verified
- Oct 2026
- First submitted
- 26 Dec 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population(THE KOREA MITRIS REGISTRY)
- ClinicalTrials.gov ID
- NCT06757049
- Acronym / sponsor ID
- KOREA MITRIS / 2024-1268
- Conditions
- Mitral Valve Insufficiency
- Keywords
- Mitral Valve Replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 60 Months
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asian(REPUBLIC OF KOREA)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular death
Time frame: 1 year post-surgery
death that results from a disease of the heart or blood vessels
Valve-related intervention
Time frame: 1 year post-surgery
a procedure to repair or replace a diseased or faulty heart valve
Structural valve deterioration and non-structural valve dysfunction
Time frame: 1 year post-surgery
abnormality that's not intrinsic to the valve
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
HOJIN KIM, PI study chair
cadiovascularthoracic surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Insufficiency, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HOJIN KIM, PI (82-2-3010-0506, rhonin.hojin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular death (time frame: 1 year post-surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.