A Prospective, Global Study Designed to Collect Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 504
- 试验地点
- 52
- 主要终点
- Hemodynamic performance as measured by peak and mean gradient by echocardiography
研究概览
简要总结
Collect real-world data 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
MOMENTIS is a prospective, observational, single-arm, multicenter global study designed to collect real-world clinical outcomes in up to 500 subjects who have received the MITRIS RESILIA Mitral Valve, Model 11400M.
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
- 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
- •Provides written informed consent
- •Willingness to follow protocol requirements
排除标准
- •Active endocarditis 3 months prior to the procedure
- •Stage 4 renal disease or requiring dialysis
- •Less than 2-year life expectancy due to non-cardiovascular life-threatening disease
- •High predicted risk of mortality prior to procedure
- •Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) score of > 8 or
- •Surgeon estimated risk of mortality of > 8
研究组 & 干预措施
Patients requiring replacement of their native or prosthetic mitral valve
Patients requiring replacement of their native or prosthetic mitral valve
干预措施: MITRIS RESILIA Mitral Valve, Model 11400M (Device)
结局指标
主要结局
Hemodynamic performance as measured by peak and mean gradient by echocardiography
时间窗: 1 year
Hemodynamic performance at 1 year as confirmed by echocardiography and Echo Core Lab evaluation
Freedom from valve related death or valve related reintervention
时间窗: 1 year
Freedom from valve related death or valve related reintervention at 1 year as determined by the Clinical Events Committee
次要结局
- Improvement from baseline for Quality of Life(1, 3, 5, 8, and 10 years post implant)
- Late linearized rates of major cardiac events(>30 days and up through 10 years post implant)
- Early rates of major cardiac events(0 to 30 days)
- Functional improvement from baseline for New York Heart Association (NYHA) Class(Annually up to 10 years post implant)