National Tunisian Registry of Valvulopathies (NATURE-VALVE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,637
- 试验地点
- 1
- 主要终点
- Valvulopathies incidence
研究概览
简要总结
The National Tunisian Registry of Valvulopathies is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of valve disease in tunisian departments of cardiology. Cardiologists from both sectors (public and private) are participating in the study, with 37 investigational centers. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) & ICH (International Conference on Harmonisation) requirements.
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
- •Patients originated from Tunisia
- •Signed informed consent
- •Patients with at least one of the following conditions :
- •moderate to severe native mitral and / or aortic and / or tricuspid native valve disease
- •and / or a history of a previous percutaneous or surgical valve intervention
- •and / or a history of infectious endocarditis
排除标准
- •Congenital valve diseases not including bicuspid aortic valve
- •Isolated pulmonary valvulopathies
结局指标
主要结局
Valvulopathies incidence
时间窗: at inclusion
Number of subjects with valvular disease (mitral or aortic or tricuspid) and willing to participate at the study
次要结局
- Major adverse cardiovascular events (MACE)(at 6 months of follow-up)