DRKS00033584招募中不适用
A prospective, global study designed to collect real-world clinical outcomes of the MITRIS RESILIA mitral valve - Europe (MOMENTIS) - MOMENTIS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. 18 years or older at the time of informed consent
- •2. Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery
- •3. Provides written informed consent
- •4. Willingness to follow protocol requirements
排除标准
- •1. Active endocarditis 3 months prior to the procedure
- •2. Stage 4 renal disease or requiring dialysis*
- •3. Less than 2-year life expectancy due to non-cardiovascular life-threatening disease
- •4. High predicted risk of mortality prior to procedure
- •STS PROM > 8 or
- •Surgeon estimated risk of mortality of > 8
- •*eGFR < 30 is excluded
研究者
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