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NCT Number: NCT05573633

Diagnosis of Postoperative Atrial Fibrillation by a Smartwatch

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, France

Location status: Recruiting

Location contact

Christophe Beyls, MD

CONTACT

[email protected]

0322087866

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECG

Procedure

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.

scanwatch

Procedure

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

Primary outcomes

  1. Variation of POAF incidence between both groups

    Time frame: 5 days

    The incidence of POAF will be compared between the two arms

Secondary outcomes

  1. percentage of asymptomatic POAF in the SW arm

    Time frame: 5 days

  2. Association between POAF and left atrial reservoir strain

    Time frame: At the enrollment in the study (day 0)

    Left atrial reservoir strain (LASr), measured by transthoracic echocardiography at discharge from the cardiothoracic intensive care unit to the conventional ward, expressed as a percentage (%), and analyzed for its association with POAF (comparison between patients with and without POAF).

  3. Feasibility of rhythm monitoring using a smartwatch

    Time frame: 5 days

    The feasibility of rhythm monitoring using a smartwatch will be assessed by wear time of the smartwatch during the protocol period

  4. Cardiovascular prognosis assessed by the occurrence of major adverse cardiovascular events (MACE)

    Time frame: 3 months and 6 months after inclusion

    Cardiovascular prognosis will be assessed using a composite endpoint of postoperative cardiovascular complications (MACE), defined according to the standards of the European Society of Anaesthesiology (ESA). MACE will be considered present if at least one of the following events occurs: stroke; Myocardial infarction; Digestive ischemia; Unplanned hospitalization for acute right and/or left heart failure decompensation; Resuscitated cardiac arrest and Cardiovascular death.

    Unit : Frequency of patients experiencing at least one MACE event (percentage, %).

  5. Percentage of patients POAF after hospital discharge.

    Time frame: 3 months and 6 months

    Percentage of patients with POAF after hospital discharge in both groups (with and without smartwatch), assessed at 3 and 6 months after discharge.

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe Beyls, MD

CONTACT

[email protected]

03 22 08 78 66

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: FAWATCH

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Oct 10, 2022
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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