Diagnosis of Postoperative Atrial Fibrillation After Cardiac Surgery by a Smartwatch: an Open-label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Variation of POAF incidence between both groups
研究概览
简要总结
The incidence of postoperative atrial fibrillation (POAF) after on-pump cardiac surgery remains high, at around 30%. POAF increases the risk of cardiac decompensation, stroke, acute myocardial infarction, and death, resulting in increased morbidity and mortality, hospital length of stay, and cost of patient management. Episodes of POAF are usually paroxysmal and asymptomatic, increasing the risk of developing permanent AF at five years by 4 to 5 times. POAF occurs between 3 and 4 days after cardiac surgery, mainly when the patient is hospitalized in a surgical ward without heart rate monitoring as opposed to critical care, where the patient benefits from continuous rhythmic monitoring. The diagnosis of POAF is therefore made with the help of a 12-lead electrocardiogram (ECG) when the patient presents clinical symptoms and when the medical staff notes a significant variation in heart rate. However, many patients with episodes of asymptomatic POAF have a higher risk of stroke and mortality than those with symptomatic POAF.
Faced with this public health problem, the development of tools for diagnosing AF is in full swing, mainly the marketing of smartwatches (SWs) that allow for the performance of 1-lead ECG. SW is also equipped with algorithms to analyze heart rate variability and diagnose asymptomatic atrial fibrillation (AF) episodes. The European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) recommend the use of smartwatches to detect AF, in particular, to reduce the economic impact of AF.
The aim of the study is to diagnose POAF within the first five days after patient discharge from the critical care unit for the cardiac surgery department.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adult patient (>18 years old)
- •The patient was hospitalized at Amiens University Hospital for on-pump cardiac surgery.
- •The patient has had a recent on-pump cardiac surgery (< 96h)
- •Patient with the motor and cognitive abilities to perform a 1-lead ECG with the smartwatch
- •The patient was transferred to the cardiac surgery department of Amiens University Hospital.
- •The beneficiary of a social security plan
- •Signature of the consent to participate in the study
排除标准
- •History of AF
- •Need for rhythmic monitoring by telemetry in cardiac intensive care for atrioventricular block and rapid supra and ventricular rhythm disorder (>140 bpm).
- •An external pacemaker connected to epicardial electrodes depends on ventricular and atrial pacing.
- •Patients already included in an interventional clinical research protocol may alter the incidence of POAF.
- •Pregnant woman
研究组 & 干预措施
smartwatches group
干预措施: scanwatch (Procedure)
no smartwatche group
干预措施: ECG (Procedure)
结局指标
主要结局
Variation of POAF incidence between both groups
时间窗: 5 days
The incidence of POAF will be compared between the two arms
次要结局
- percentage of asymptomatic POAF in the SW arm(5 days)
- Association between POAF and left atrial reservoir strain(At the enrollment in the study (day 0))
- Feasibility of rhythm monitoring using a smartwatch(5 days)
- Cardiovascular prognosis assessed by the occurrence of major adverse cardiovascular events (MACE)(3 months and 6 months after inclusion)
- Percentage of patients POAF after hospital discharge.(3 months and 6 months)