Natural History and Recurrence Rate of Atrial Fibrillation After the First, COVID-19-Related Atrial Arrhythmic Episode: A Prospective Evaluation Using Continuous Cardiac Rhythm Monitoring
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 14
- 主要终点
- AF Progression
研究概览
简要总结
The unCOVer-AF prospective, multicenter registry aims at determining the natural history of atrial fibrillation (AF) via continuous cardiac rhythm monitoring in patients with a first arrhythmic episode during COVID-19 hospitalization.
详细描述
Coronavirus Disease 2019 (COVID-19) is a novel coronavirus strain disease, which has rapidly spread worldwide with more than 100 million confirmed cases to date. COVID-19 is mainly characterized by respiratory symptoms; however, patients can exhibit a wide range of clinical manifestations, including cardiovascular complications. Among them, supraventricular and ventricular arrhythmias have been described in patients at different stages of disease severity. According to a recent study on 9564 COVID-19 patients, 17.6% developed AF during hospitalization, 65.7% of whom without a past arrhythmic history.
Several factors (e.g., hypoxia, systemic inflammatory response, myocardial injury) may interact with a preexisting substrate and act as a trigger for AF initiation. Nonetheless, the pathophysiology of COVID-19-related new-onset AF remains elusive. It is unknown whether the disease merely acts as a transient arrhythmia initiator or promotes long-term atrial electrophysiological and structural changes which may facilitate AF recurrence and progression.
Therefore, the investigators designed a multicenter, prospective registry to assess the natural history of AF via continuous cardiac rhythm monitoring (ILR, PMK, ICD) in patients with a first AF episode during COVID-19 hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Age> 18 years;
- •Confirmed infection with SARS-CoV-2;
- •Patients with a first clinical episode of AF ≥30 s at admission or during hospitalization for COVID-19;
- •Patients with:
- •implantation of an ILR, a PMK, or an ICD during COVID-19 hospitalization or within 30 days after hospital discharge, or
- •an ILR, a PMK, or an ICD implanted before COVID-19 hospitalization.
排除标准
- •History of AF or flutter irrespective of type;
- •Moderate/severe mitral stenosis;
- •Mechanical prosthetic heart valve(s);
- •Kidney failure treated with permanent dialysis;
- •Any condition (e.g. psychiatric illness, dementia) or situation, that in the investigators opinion could put the subject at significant risk, confound the study results, or interfere significantly with the subject participation in the study;
- •Unwillingness to participate.
结局指标
主要结局
AF Progression
时间窗: 3 years
AF Burden
时间窗: 3 years
AF burden is defined as cumulative duration of all AF episodes lasting ≥30 s from the first adjudicated AF episode onward, divided by total duration of monitoring.
Time to adjudicated ischemic stroke/transient ischemic attack (TIA)/systemic arterial embolism
时间窗: 3 years
次要结局
- Composite of all-cause mortality, stroke and bleeding(3 years)
- Time to adjudicated cardiovascular death(3 years)
研究者
Andrea Natale
Executive Medical Director
Texas Cardiac Arrhythmia Research Foundation