Anticoagulant and Antiarrhythmic Management Based on Continuous Rhythm Monitoring and Cardiac Imaging in Patients at Low Risk for Cardiovascular Events Following Direct Current Cardioversion for New Onset Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Time to AF recurrence
研究概览
简要总结
This pilot study aims to assess the feasibility and safety of using an ILR to identify the incidence of recurrent AF after an episode of newly diagnosed AF. The study further aims to assess the risk of AF recurrence in this low risk population based on left atrial and left atrial appendage anatomic and functional indices in addition to the standardized clinical CHA2DS2-Vasc score.
详细描述
There is a significant incidence of recurrent AF following initial diagnosis of AF.
Inclusion of left atrial (LA) and left atrial appendage (LAA) abnormalities together with risk prediction of CVA using CHA2DS2-Vasc score will identify patients at low or high risk for adverse cardiovascular events in patients with manifest and silent AF.
Patients requiring cardioversion have higher risk of recurrent AF in follow up.
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
- •Age ≥ 18 years
- •Newly diagnosed AF
- •Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule
排除标准
- •Patient is participating in or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint
- •Patient received an organ transplant, or is on a waiting list.
- •Patient is not able to follow instructions for remote monitoring 4 Prior history of AF
结局指标
主要结局
Time to AF recurrence
时间窗: 3 years
Time to AF recurrence based on clinical or ILR monitoring
次要结局
- All cause death(30 days; 6 months; 1 year; 2 years; 3 years)
- AF related re hospitalizations(3 years)
- Occurrence of CVA(3 years)
- Major and minor bleeding(3 years)