Post-Market Clinical Follow-up Study of Edwards Lifesciences MITRIS RESILIA Mitral Valve in Chinese Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 13
- 主要终点
- Primary Safety outcome - Kaplan Meier (KM) rate of valve related death or reintervention
研究概览
简要总结
Collect clinical outcomes on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures.
详细描述
The trial is a Multicenter, prospective, single-arm, post-market study designed to collect clinical outcomes in up to 250 Subjects who have received the MITRIS RESILIA Mitral Valve, Model 11400M.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older at the time of informed consent
- •Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery
- •Provide signed written informed consent prior to the study participation
- •Willingness to follow protocol requirements
排除标准
- •Active endocarditis 3 months prior to the procedure
- •Stage 4 renal disease or requiring dialysis (eGFR < 30 is excluded)
- •Less than 2-year life expectancy due to non-cardiovascular life-threatening disease
- •High predicted risk of mortality prior to procedure - STS Predicted Risk of Mortality (PROM) > 8 or Surgeon estimated risk of mortality of > 8 (STS PROM risk calculation score must be used for patients undergoing Isolated Mitral Valve Replacement (MVR) or MVR+ Coronary Artery Bypass Grafting (CABG). Surgeon estimated risk of mortality may only be used for patients who do not qualify for evaluation against those surgical models.)
- •Participating in a drug or device study that has not reached its primary endpoint. Note: Participation in national registries is not an exclusion.
结局指标
主要结局
Primary Safety outcome - Kaplan Meier (KM) rate of valve related death or reintervention
时间窗: 1 year
Freedom from valve related death or valve related reintervention at 1 year as determined by the CEC.
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Average Mean Gradient Measurements
时间窗: 1 year
Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Average Peak Gradients Measurements
时间窗: 1 year
Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Transvalvular regurgitation
时间窗: 1 year
Transvalvular leak is where a heart valve doesn't close properly, allowing blood to flow backward through the valve itself. Transvalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Paravalvular leak
时间窗: 1 year
Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
次要结局
- Performance outcome - Hemodynamics by echocardiography Subject's Average Mean Gradient Measurements(10 years)
- Performance outcome - Hemodynamics by echocardiography - Subject's Average Peak Gradients Measurements(10 years)
- Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Transvalvular regurgitation(10 years)
- Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Paravalvular leak(10 years)
- Adverse Events(10 years)
- New York Heart Association (NYHA) Classification(10 years)