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Recruiting NCT05573633

Diagnosis of Postoperative Atrial Fibrillation by a Smartwatch

No phase Interventional Atrial Fibrillation Cardiac Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ECG, scanwatch.
Who it may be relevant to
Registry conditions: Atrial Fibrillation, Cardiac Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure ECG
    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.
  • Procedure scanwatch
    POAF will be diagnosed with a Withings SM (ScanWatch) by a 1-lead ECG and/or 12-lead ECG.

Primary outcome measures

  • Variation of POAF incidence between both groups [Time frame: 5 days]
Secondary outcome measures (5)
  • percentage of asymptomatic POAF in the SW arm [Time frame: 5 days]
  • Association between POAF and left atrial reservoir strain [Time frame: At the enrollment in the study (day 0)]
  • Feasibility of rhythm monitoring using a smartwatch [Time frame: 5 days]
  • Cardiovascular prognosis assessed by the occurrence of major adverse cardiovascular events (MACE) [Time frame: 3 months and 6 months after inclusion]
  • Percentage of patients POAF after hospital discharge. [Time frame: 3 months and 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

France · 1 center
  • CHU Amiens Picardie — Amiens

Publications

  • Beyls C, Hermida A, Mollet N, Vermander M, Noe F, Bara H, Josse E, Khamari M, Diouf M, Abou-Arab O, Mahjoub Y. Diagnosis of postoperative atrial fibrillation using smartwatch monitoring after cardiac surgery: protocol for the FAWATCH single-centre, open-label, randomised controlled trial. BMJ Open. 2026 Jul 17;16(7):e118691. doi: 10.1136/bmjopen-2026-118691. PMID 42468947

Identifiers

NCT: NCT05573633 · PI2021_843_0228

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗