Diagnosis of Postoperative Atrial Fibrillation by a Smartwatch

Study Overview
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Brief Summary
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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.

Official Title
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Diagnosis of Postoperative Atrial Fibrillation After Cardiac Surgery by a Smartwatch: an Open-label Randomized Controlled Trial

Conditions
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Atrial Fibrillation, Cardiac Surgery

Intervention / Treatment
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* Procedure: ECG
* Procedure: scanwatch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: smartwatches group<br> | Procedure: scanwatch<br>* POAF will be diagnosed with a Withings SM (ScanWatch). FAPO diagnosed by the SW will have to be confirmed by a 12-lead ECG.<br>|
| Active Comparator: no smartwatche group<br> | Procedure: ECG<br>* the POAF will be diagnosed using a 12-lead ECG and according to the usual monitoring protocols for patients in the cardiac surgery department of Amiens University Hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of POAF incidence between both groups | The incidence of POAF will be compared between the two arms | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of asymptomatic PAOF in the SW arm |  | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smartwatch, Atrial Fibrillation, perioperative atrial fibrillation, cardiac surgery