Pilot Study: Tailored Anticoagulation for Noncontinuous AF
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 10
- 主要终点
- Total Cumulative Days on Anticoagulation
研究概览
简要总结
The purpose of this study is to determine whether it is safe to stop anticoagulation medication in patients with a history of atrial fibrillation (AF) based on information from a pacemaker or implantable cardioverter defibrillator (ICD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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 has a St Jude Medial device that is compatible with Merlin.net (remote monitoring)
- •Patient has history of atrial fibrillation (non-continuous)
- •Patient must be taking a a blood thinner medication other than warfarin or aspirin for atrial fibrillation
- •Patient is willing to complete a questionnaire
排除标准
- •Patient is in atrial fibrillation all of the time
- •Patient has a history of stroke or blood clot
- •Patient is on warfarin or coumadin
- •Patient cannot be taken off of his blood thinner medication due to another medical condition
- •Patient is not capable of sending a remote device transmission to doctor once a week
研究组 & 干预措施
Control
Remote transmissions were scheduled per each institution's device monitoring protocol. Anticoagulation was initiated/discontinued based on standard of care/guidelines as prescribed by doctor
Tailored Anticoagulation (TAC)
Anticoagulation was initiated or discontinued based on atrial tachycardia / atrial fibrillation (AT/AF) burden as assessed through frequent remote transmissions via Merlin.net.
Patients sent in biweekly remote transmissions, automatic alert-triggered transmissions for AT/AF burden above a set threshold, and unscheduled patient-activated transmissions as needed
干预措施: Drug (Direct thrombin or Factor Xa inhibitor) (Other)
结局指标
主要结局
Total Cumulative Days on Anticoagulation
时间窗: one year
To assess the reduction in time on anticoagulation, the cumulative total number of days on anticoagulation for each group throughout the follow-up period was determined. This study was designed as a pilot/feasibility study and therefore was not powered to detect thromboembolic events. Per study protocol, all patients completed a 30 day run-in period following enrollment during which anticoagulation could not be stopped regardless of AT/AF burden.
次要结局
未报告次要终点