NCT07434674招募中不适用
Incidence of Long-TeRm Atrial Fibrillation After Acute Illness (ILR-AF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time to first documented event of AF by 12 months
研究概览
简要总结
The investigators seek to conduct a prospective study to assess the recurrence of AF in patients with acute AF using a long-term ECG monitoring strategy with an insertable cardiac monitor (ICM), which is clinically indicated in this scenario as part of the standard of care. The investigators hypothesize that patients diagnosed with acute AF in the setting of cardiac surgery will have higher rates of AF recurrence than acute AF diagnosed in the setting of non-cardiac surgery or medical illness.
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 has an existing clinical indication for implantation of an insertable cardiac monitor (ICM) and will undergo ICM implantation as part of their standard medical care.
- •Patient is scheduled to receive or has received a Boston Scientific LUX-DX™ insertable cardiac monitor.
- •Episode of acute AF. Acute AF is defined as AF detected in an acute care setting or during an acute illness. Before enrollment, the following tests are minimally required as standard tests to establish the diagnosis of acute AF:
- •12-lead ECG for AF detection
- •24-h ECG or telemetry monitoring for AF detection and PAC analysis
- •Patient or legally authorized representative signs and dates the patient consent form.
- •Patient is ≥18 years old.
- •Patient is willing and able to comply with all study procedures and attend the required follow-up visits for the duration of the study.
排除标准
- •Patient has a known history of AF or atrial flutter prior to the index acute AF episode.
- •Patient has another indication for antiarrhythmic medications according to AHA/ACC/HRS guidelines, independent of the acute AF episode.
- •Patient has a permanent contraindication to oral anticoagulation (OAC) that, in the opinion of the treating physician, would preclude any future consideration of OAC for AF management.
- •Patient is currently enrolled in another clinical trial that will affect the objectives or endpoints of this study.
- •Patient's life expectancy is less than one year, as determined by the treating physician.
- •Patient is pregnant.
- •Patient has a current indication for implant with a cardiac implantable electronic device (CIED) such as a pacemaker or defibrillator, or an implantable hemodynamic monitoring system, as the study intervention would be redundant or potentially interfere with the clinical indication.
- •Patient is not fit, able, or willing to follow the required procedures of the Clinical Investigation Plan.
研究组 & 干预措施
ILR
结局指标
主要结局
Time to first documented event of AF by 12 months
时间窗: 12 months
The primary objective is to determine the time to first documented event of AF by 12 months of continuous rhythm monitoring, stratified by the setting of acute AF diagnosis (cardiac surgery, non-cardiac surgery, and medical illness).
次要结局
- Time to first documented AF by 6 months(6 months)
- Time to first documented AF episode lasting ≥ 5 minutes(12 months)
- Mean AF burden(12 months)
- Mean AF episode length(12 months)
- Change in use of oral anticoagulation and antiarrhythmic drugs(12 months)
- Quality of life scores (SF-36)(12 months)
- Incidence of hospitalization(12 months)
- Change in medication use(12 months)
- Incidence of stroke(12 months)
- Incidence of death(12 months)
研究者
Jonathan Hsu
Professor of Medicine
University of California, San Diego
研究点 (1)
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