National Tunisian Registry of Cardiac Implantable Electronic Devices (NATURE-CIED)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,518
- 试验地点
- 1
- 主要终点
- Incidence of patients undergoing cardiac implantable electronic devices in Tunisia
研究概览
简要总结
The National Tunisian Registry of Cardiac Implantable Electronic Devices is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of cardiac implantable electronic Devices in Tunisia. Cardiologists from both sectors (public and private) are participating in the study, with 26 investigational centers. Data is 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 undergoing a cardiac implantable electronic device procedure
排除标准
- •Informed Consent not given
结局指标
主要结局
Incidence of patients undergoing cardiac implantable electronic devices in Tunisia
时间窗: at inclusion
Number of subjects with heart disease (heart failure, rythm disorder) and willing to participate at the study and who are eligible for cardiac implantable electronic devices procedures
次要结局
- Heart complication(at 12 months of follow-up)