Indian Heart Rhythm Society (IHRS) Registry of Atrial Fibrillation: Patient Characteristics and Clinical Management Practices
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
- 19
- 主要终点
- oPatient Characteristics (demographics)
研究概览
简要总结
The objective of this project is the development of a registry of Atrial Fibrillation patients in xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /India in order to: xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
1. Find out key demographic features of atrial fibrillation in India
2. Explore how atrial fibrillation is first detected
3. Determine current treatment practices of AF in India: Rate vs Rhythm Control with reason for choosing a particular treatment strategy
4. Use of Anti- thrombotic agents
The data will enhance our understanding on the demographics of atrial fibrillation in India, its treatment patterns, and the reasons for lack of optimal treatment as per the current guidelines. It will also give important information on the current prevalence patterns, as compared to other countries and populations. The data will help identify focus areas that require urgent attention, including patient and physician education. It will also be possible to do subset analysis on this data for populations such as young patients with valvular AF in order to improve their management and reduce complications
- IHRS-AF is a national, observational, cross-sectional registry of patients with AF.
· Approval of the local Institutional Review Board/ Independent Ethics Committee (IRB/IEC) will be sought by the investigator before initiating the registry at each institution.
· Approximately 20 electrophysiology specialists and cardiologists managing cardiac arrhythmias will be selected as investigators.
- A total of 1000 patients would be recruited over a period of 12 months.
- Each investigator will enroll around 50 patients.
- Eligible patients must have current AF (any type or treatment), or a history of AF and at least one AF episode in the past 12 months documented by standard ECG or ECG-Holter monitoring.
· Schedule of visits – Baseline, 6 months and 12 months ( Window Period ±1 Month)
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female (any age) History of AF or current AF (treated or not and whatever the rhythm at inclusion), with at least one AF episode in the last 12 months (ECG or ECG-Holter monitoring) Signed written informed consent obtained from the patient or his/her legal representative.
排除标准
- •Mental disorder that makes the accuracy of the collected information uncertain.
结局指标
主要结局
oPatient Characteristics (demographics)
时间窗: 1,6 and 12 month after enrollment/baseline
oInitial presentation of AF
时间窗: 1,6 and 12 month after enrollment/baseline
oCurrent Management Practices
时间窗: 1,6 and 12 month after enrollment/baseline
次要结局
- oAF control at 6 months & 12 months(oOther clinical outcomes (thromboembolic events - CV events & stroke))