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.
Study Type
OBSERVATIONAL
Enrollment
200
Asan Medical Center
Seoul, SONGPA-GU, South Korea
RECRUITINGCardiovascular death
death that results from a disease of the heart or blood vessels
Time frame: 1 year post-surgery
Valve-related intervention
a procedure to repair or replace a diseased or faulty heart valve
Time frame: 1 year post-surgery
Structural valve deterioration and non-structural valve dysfunction
abnormality that's not intrinsic to the valve
Time frame: 1 year post-surgery
Peak and mean trans-mitral valve pressure gradient and effective orifice area
echocardiographic parameters used to assess mitral valve disease
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 month,1 year,2 year,3 year, 5year post-surgery
Stroke (ischemic or hemorrhagic)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
a medical emergency that occurs when blood flow to the brain is blocked or a blood vessel in the brain bursts
Time frame: 6 month,1 year,2 year,3 year, 5year post-surgery
Hospitalization due to cardiovascular disease
a hospital admission with a defined cardiovascular cause
Time frame: 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.)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 month,1 year,2 year,3 year, 5year post-surgery