Clinical trial NCT05573633: Diagnosis of Postoperative Atrial Fibrillation by a Smartwatch
Official title: Diagnosis of Postoperative Atrial Fibrillation After Cardiac Surgery by a Smartwatch: an Open-label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Cardiac Surgery
Keywords: smartwatch
Atrial Fibrillation
perioperative atrial fibrillation
cardiac surgery
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Variation of POAF incidence between both groups
timeFrame: 5 days
Secondary outcomes:
measure: percentage of asymptomatic PAOF in the SW arm
timeFrame: 5 days
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
References: