Mitral Valve Screening Survey (MVSS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 16
- 主要终点
- All-cause mortality
研究概览
简要总结
This study aims to examine the clinical profile/anatomical characteristics and natural history of patients who subsequently fail screening for transcatheter mitral valve intervention (TMVI).
详细描述
Numerous transcatheter mitral valve interventions have emerged as a treatment option for patients with mitral valve disease. Development of transcatheter mitral valve repair (TMVr) and transcatheter mitral valve replacement (TMVR) continues to progress with ongoing rigorous clinical trials of several experimental devices. However, despite being referred for TMVI, most patients do not pass stringent screening criteria for these investigational devices and are not offered TMVI.
In this prospective multicenter registry, baseline demographics, anatomical/imaging characteristics, and clinical outcomes of patients who fail screening for TMVI will be prospectively collected into a registry database.
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
- •Subject failed screening for TMVI
排除标准
- •Under 18 years of age
- •Subject unable or unwilling to give informed consent
- •Subject proceeded with TMVI.
结局指标
主要结局
All-cause mortality
时间窗: 1 year
次要结局
- Reason for screen failure(Baseline)
- All-cause mortality(30 days, 1 year, and annually up to 5 years)
- Hospitalizations(30 days, 1 year, and annually up to 5 years)
- Mitral intervention(30 days, 1 year, and annually up to 5 years)