Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population(THE KOREA MITRIS REGISTRY)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cardiovascular death
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Cardiovascular death
时间窗: 1 year post-surgery
death that results from a disease of the heart or blood vessels
Valve-related intervention
时间窗: 1 year post-surgery
a procedure to repair or replace a diseased or faulty heart valve
Structural valve deterioration and non-structural valve dysfunction
时间窗: 1 year post-surgery
abnormality that's not intrinsic to the valve
次要结局
- 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)
- Stroke (ischemic or hemorrhagic)(6 month,1 year,2 year,3 year, 5year post-surgery)
- Hospitalization due to cardiovascular disease(6 month,1 year,2 year,3 year, 5year post-surgery)
- Bleeding(6 month,1 year,2 year,3 year, 5year post-surgery)
- Infective endocarditis related to the mitral valve(6 month,1 year,2 year,3 year, 5year post-surgery)
- Valve-related reintervention(6 month,1 year,2 year,3 year, 5year post-surgery)
- Structural valve deterioration or non-structural valve dysfunction(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)
- Valve thrombosis(6 month,1 year,2 year,3 year, 5year post-surgery)
研究者
HO JIN KIM
Associate Professor
Asan Medical Center