NCT00995748已完成不适用
REgistry on Cardiac Rhythm disORDers in Asia-Pacific
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 2,674
- 试验地点
- 1
- 主要终点
- Rate of therapeutic success by patients in sinus rhythm or heart rate control at target (< 80 beats per minute at rest)
研究概览
简要总结
The Primary objective of this registry is to assess the control of Atrial Fibrillation (AF) over one year in patients attending clinical or specialized practices.
The Secondary objectives are:
- To describe key demographics and treatment features in AF patients visiting cardiologists in various countries in Asia-Pacific.
- To establish correlation between control of AF and clinical outcomes.
- To establish correlation between treatment strategies and AF control.
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
- •Patient presenting with either:
- •History of atrial fibrillation diagnosed < 1 year by standard Electro-Cardiogram (ECG) or by ECG-Holter monitoring (treated or not or whatever rhythm at inclusion).
- •New atrial fibrillation diagnosed by standard ECG or by ECG-Holter monitoring at inclusion visit.
- •Patient eligible for a pharmacological treatment of AF (by rhythm or rate control agent).
排除标准
- •AF due to transient cause (thyrotoxicosis, alcohol intoxication, acute phase of myocardial infarction, pericarditis, myocarditis, electrocution, pulmonary embolism or other pulmonary disease, hydroelectrolytic disorder, metabolic disorder, etc.).
- •Post cardiac surgery AF (≤3 months).
- •Mentally disabled patients unable to understand or sign the written informed consent.
- •Patients unable to comply with follow-up visits.
- •Patients with pacemaker, Implantable Cardioverter Defibrillator (ICD).
- •Patients scheduled for pulmonary vein ablation, AV node/His bundle ablation, or pacemaker implantation.
- •Patient included in any clinical trial in the previous 3 months.
- •Pregnant or breastfeeding women.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Rate of therapeutic success by patients in sinus rhythm or heart rate control at target (< 80 beats per minute at rest)
时间窗: At 12 ± 3 months follow-up
Comparison of clinical outcomes (Cardiovascular death, Stroke, Myocardial infarction, etc) for patients in rhythm versus rate control strategies
时间窗: At 12 ± 3 months follow-up
次要结局
- Treatment effectiveness evaluated by the proportion of patients in sinus rhythm(At 1 year follow-up)
研究者
研究点 (1)
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