Retrospective Registry Providing Baseline Data on the Outcome of Left Atrial (LA) or LA Appendage (LAA) Thrombus in Patients With Nonvalvular Atrial Fibrillation (AF) or Atrial Flutter After Standard of Care (SoC) Anticoagulant Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 160
- 主要终点
- Thrombus resolution (completely disappeared) rate confirmed on TEE.
研究概览
简要总结
Thrombus outcome data will be collected retrospectively during 2011-2012 as a historical baseline of SoC with oral VKA (Vitamin K Antagonist(s) for the treatment of patients with nonvalvular AF or atrial flutter documented with LA/ LAA thrombi on transesophag-eal echocardiography (TEE).
The study is a company-sponsored, global, multi-center, retrospective, non-interventional study. Patients who suffered from hemodynamically stable nonvalvular AF or atrial flutter and had a diagnosed LA/ LAA thrombus between January 1st, 2011 and December 31st, 2012 will be identified through screening and review of medical records and included in the registry. Retrospective patient data will be collected from May 2nd, 2013 to May 2nd, 2014. The observation of each patient will cover the period from the diagnosis of an LA/ LAA thrombus until the end-of-treatment TEE following the 3-12 week SoC anticoagulation (AC) therapy. If no end-of-treatment TEE has been performed during 3-12 weeks of AC therapy, the observational period will end at 12 weeks after diagnosis at the latest. If more than one TEE was performed during treatment, the thrombus outcome will be collected from the last TEE performed within 12 weeks of treatment start.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
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
- •Men or women age ≥ 18 years at data recording
- •Hemodynamically stable nonvalvular AF or atrial flutter
- •Documented LA/ LA thrombus on TEE
排除标准
- •Valvular AF ( ESC 2012 definition)
- •History of cardiac thrombus confirmed on TEE
- •Intracardiac tumors, e.g. atrial myxoma
- •Active endocarditis
结局指标
主要结局
Thrombus resolution (completely disappeared) rate confirmed on TEE.
时间窗: after 3-12 weeks of SoC treatment or lost to follow up, whichever is later
次要结局
- Stroke or non central nervous system (CNS) systemic thromboembolism rate(after 3-12 weeks of SoC treatment or lost to follow up, whichever is later)
- All bleeding (major, non-major, unknown severity) rates(after 3-12 weeks of SoC treatment or lost to follow up, whichever is later)
