Atrial FibrillationFAWATCHNCT05573633
Diagnosis of Postoperative Atrial Fibrillation by a Smartwatch
A study testing ECG and scanwatch in people with Atrial Fibrillation and Cardiac Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Cardiac Surgery
- What is being tested?
- ECG and scanwatch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2022to 6 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens
Christophe Beyls, MD, 0322087866, Beyls.Christophe@chu-amiens.fr
About this study
Official title: Diagnosis of Postoperative Atrial Fibrillation After Cardiac Surgery by a Smartwatch: an Open-label Randomized Controlled Trial
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.
- Conditions
- Atrial Fibrillation, Cardiac Surgery
- Being tested
- ECG, scanwatch
- Keywords
- smartwatch, Atrial Fibrillation, perioperative atrial fibrillation, cardiac surgery
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGProcedure or surgery
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.
scanwatchProcedure or surgery
POAF will be diagnosed with a Withings SM (ScanWatch) by a 1-lead ECG and/or 12-lead ECG.
| Study group | Role | What they receive |
|---|---|---|
| smartwatches group | Experimental | Not described Receives: Procedure: scanwatch |
| no smartwatche group | Active comparator | Not described Receives: Procedure: ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of POAF incidence between both groups
The incidence of POAF will be compared between the two arms
Measured: 5 days
Secondary outcomes (5)
percentage of asymptomatic POAF in the SW arm
Measured: 5 days
Association between POAF and left atrial reservoir strain
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).
Measured: At the enrollment in the study (day 0)
Feasibility of rhythm monitoring using a smartwatch
The feasibility of rhythm monitoring using a smartwatch will be assessed by wear time of the smartwatch during the protocol period
Measured: 5 days
Cardiovascular prognosis assessed by the occurrence of major adverse cardiovascular events (MACE)
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, %).
Measured: 3 months and 6 months after inclusion
Percentage of patients POAF after hospital discharge.
Percentage of patients with POAF after hospital discharge in both groups (with and without smartwatch), assessed at 3 and 6 months after discharge.
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start6 Oct 2022
- Primary completion6 Oct 2027 (estimated)
- Study completion6 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573633
- Sponsor's protocol ID
- PI2021_843_0228
- Acronym
- FAWATCH
- Status last verified
- Feb 2026
- First submitted
- 6 Oct 2022
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 42468947
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Postoperative Atrial Fibrillation After Cardiac Surgery by a Smartwatch: an Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05573633
- Acronym / sponsor ID
- FAWATCH / PI2021_843_0228
- Conditions
- Atrial Fibrillation, Cardiac Surgery
- Keywords
- smartwatch, Atrial Fibrillation, perioperative atrial fibrillation, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 6 Oct 2027 (estimated)
- Study completion
- 6 Jul 2028 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smartwatches group | Experimental | Procedure: scanwatch |
| no smartwatche group | Active comparator | Procedure: ECG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECGthe 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 or surgery | no smartwatche group |
| scanwatchPOAF will be diagnosed with a Withings SM (ScanWatch) by a 1-lead ECG and/or 12-lead ECG. | Procedure or surgery | smartwatches group |
Primary outcome
Variation of POAF incidence between both groups
Time frame: 5 days
The incidence of POAF will be compared between the two arms
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Derived from this study: PubMed 42468947Beyls 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG and scanwatch in people with Atrial Fibrillation and Cardiac Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe Beyls, MD (03 22 08 78 66, beyls.christophe@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of POAF incidence between both groups (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05573633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.