Mitral Valve Insufficiency
Conditions
Keywords
Mitral Valve Replacement
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.
Interventions
None listed
Sponsors
Edwards Lifesciences
Asan Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular death | 1 year post-surgery | death that results from a disease of the heart or blood vessels |
| Valve-related intervention | 1 year post-surgery | a procedure to repair or replace a diseased or faulty heart valve |
| Structural valve deterioration and non-structural valve dysfunction | 1 year post-surgery | abnormality that's not intrinsic to the valve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Valve-related death | 6 month,1 year,2 year,3 year, 5year post-surgery | 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 |
| Stroke (ischemic or hemorrhagic) | 6 month,1 year,2 year,3 year, 5year post-surgery | a medical emergency that occurs when blood flow to the brain is blocked or a blood vessel in the brain bursts |
| Hospitalization due to cardiovascular disease | 6 month,1 year,2 year,3 year, 5year post-surgery | a hospital admission with a defined cardiovascular cause |
| Bleeding | 6 month,1 year,2 year,3 year, 5year post-surgery | BARC classification use.(A standardized tool for defining and categorizing bleeding events in clinical trials.) |
| Peak and mean trans-mitral valve pressure gradient and effective orifice area | 6 month,1 year,2 year,3 year, 5year post-surgery | echocardiographic parameters used to assess mitral valve disease |
| Valve-related reintervention | 6 month,1 year,2 year,3 year, 5year post-surgery | any invasive procedure performed on the aortic valve, coronary button, or proximal aorta |
| Structural valve deterioration or non-structural valve dysfunction | 6 month,1 year,2 year,3 year, 5year post-surgery | a type of valve dysfunction that involves permanent damage to the valve |
| Valve thrombosis | 6 month,1 year,2 year,3 year, 5year post-surgery | 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 |
| Infective endocarditis related to the mitral valve | 6 month,1 year,2 year,3 year, 5year post-surgery | a bacterial, viral, or fungal infection of the mitral valve leaflets |
| All-cause death | 6 month,1 year,2 year,3 year, 5year post-surgery | the total number of deaths from any cause in a given population over a specific period of time |
| cardiovascular death | 6 month,1 year,2 year,3 year, 5year post-surgery | a death that results from a disease of the heart or blood vessels |
Countries
South Korea
Contacts
Primary ContactHOJIN KIM, PI
Backup ContactYUKYUNG CHOI, CRA
Outcome results
None listed