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| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
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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
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak and mean trans-mitral valve pressure gradient and effective orifice area | echocardiographic parameters used to assess mitral valve disease | 6 month,1 year,2 year,3 year, 5year post-surgery |
| All-cause death |
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Inclusion Criteria:
Exclusion Criteria:
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Asian(REPUBLIC OF KOREA)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HOJIN KIM, PI | Contact | 82-2-3010-0506 | rhonin.hojin@gmail.com | |
| YUKYUNG CHOI, CRA | Contact | 82-2-2045-3815 | cyk1108@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| HOJIN KIM, PI | cadiovascularthoracic surgery | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | SONGPA-GU | South Korea |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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the total number of deaths from any cause in a given population over a specific period of time
| 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 | 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 | 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 | 6 month,1 year,2 year,3 year, 5year post-surgery |
| Hospitalization due to cardiovascular disease | a hospital admission with a defined cardiovascular cause | 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.) | 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 | 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 | 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 | 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 | 6 month,1 year,2 year,3 year, 5year post-surgery |