Postoperative Atrial FibrillationTHO-FA-WATCHNCT06724718
Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch
A study testing smartwatch and ECG in people with Postoperative Atrial Fibrillation and Thoracic Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Postoperative atrial fibrillation (POAF) occurs in approximately 20% of patients following thoracic surgery. Early diagnosis is essential to prevent complications such as heart failure, stroke, myocardial infarction, and increased mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Atrial Fibrillation, Thoracic Surgery, Smartwatches
- What is being tested?
- smartwatch and ECG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2025to Dec 2027
- 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
- Adults (>18 years old).
- Patients undergoing major thoracic surgery with one-lung ventilation within the past 48 hours.
- Scheduled pneumonectomy or lobectomy.
- Admission to a conventional surgical unit postoperatively.
- Ability to perform single-lead ECG using a smartwatch.
- Coverage under a social security system.
- Signed informed consent
Who cannot join
- History of atrial fibrillation.
- Requirement for telemetry for AV block or tachyarrhythmias (>140 bpm).
- Dependency on a pacemaker.
- Participation in another interventional clinical trial affecting POAF incidence.
- Mediastinal, pleural, or chest wall surgery.
- Reoperations or surgeries performed more than 48 hours prior.
- Pregnant women.
- Patients under guardians or similar legal protection.
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
Centre hospitalier Amiens
Amiens, 80054
Pierre Huette, MD, 33322088371, Huette.pierre@chu-amiens.fr
Christophe Beyls, MD
About this study
Postoperative atrial fibrillation (POAF) occurs in approximately 20% of patients following thoracic surgery. Early diagnosis is essential to prevent complications such as heart failure, stroke, myocardial infarction, and increased mortality. Smartwatches equipped with single-lead ECG capabilities and algorithms to detect asymptomatic atrial fibrillation (AF) offer a potential solution. This study aims to evaluate the effectiveness of smartwatches in detecting POAF compared to standard care.
- Conditions
- Postoperative Atrial Fibrillation, Thoracic Surgery, Smartwatches, Rhythm Monitoring, Cardiovascular Prognosis, Asymptomatic Atrial Fibrillation
- Being tested
- smartwatch, ECG
- Keywords
- Postoperative atrial fibrillation, thoracic surgery, smartwatches, rhythm monitoring, cardiovascular prognosis, asymptomatic atrial fibrillation, randomized trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smartwatchOther
Patients in the smartwatch group will undergo rhythm monitoring with a smartwatch
ECGOther
Detected POAF episodes will be confirmed via a 12-lead ECG
| Study group | Role | What they receive |
|---|---|---|
| Smartwatch group | Experimental | Experimental intervention using smartwatches for rhythm monitoring. Receives: Other: smartwatch; Other: ECG |
| Control group | Active comparator | Standard care without smartwatch monitoring Receives: Other: ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of POAF
the incidence of POAF within seven days after scheduled thoracic surgery.
Measured: at day 7
Secondary outcomes (8)
Rate of asymptomatic POAF
Rate of asymptomatic POAF, evaluated using the EHRA symptom score
Measured: at day 7
Cardiovascular prognosis
Cardiovascular prognosis assessed through a composite outcome (MACE)
Measured: at day 3
Cardiovascular prognosis
Cardiovascular prognosis assessed through a composite outcome (MACE)
Measured: at 6 months
Feasibility of rhythm monitoring with a smartwatch
Feasibility of rhythm monitoring with a smartwatch, measured by device usage time and the proportion of successful single-lead ECGs performed.
Measured: at day 7
Recurrence of AF
Recurrence of AF
Measured: at 3 months
Recurrence of AF
Recurrence of AF
Measured: at 6 months
management of AF
management of AF
Measured: at 3 months
management of AF
management of AF
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Jun 2025
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (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 Postoperative 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Clinique Victor Pauchet
- Responsible party
- Sponsor
- Investigators
- Pierre Huette, MD, Principal investigator, Centre Hospitalier Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724718
- Sponsor's protocol ID
- PI2023_843_0139
- Acronym
- THO-FA-WATCH
- Status last verified
- Jun 2025
- First submitted
- 5 Dec 2024
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huette P, Beyls C, Diouf M, Ibrahima A, Haye G, Guilbart M, Lefebvre T, Bayart G, Lhotellier F, Radji M, Walczak KA, Caboche M, De Dominicis F, Georges O, Berna P, Merlusca G, Hermida A, Traulle S, Dupont H, Mahjoub Y, Abou-Arab O; THOFAWATCH Study Group. Study protocol: diagnosis of atrial fibrillation in postoperative thoracic surgery using a smartwatch, an open-label randomised controlled study (THOFAWATCH trial). BMJ Open. 2025 Apr 9;15(4):e097765. doi: 10.1136/bmjopen-2024-097765.
PubMed 40204329
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch
- ClinicalTrials.gov ID
- NCT06724718
- Acronym / sponsor ID
- THO-FA-WATCH / PI2023_843_0139
- Conditions
- Postoperative Atrial Fibrillation, Thoracic Surgery, Smartwatches, Rhythm Monitoring, Cardiovascular Prognosis, Asymptomatic Atrial Fibrillation
- Keywords
- Postoperative atrial fibrillation, thoracic surgery, smartwatches, rhythm monitoring, cardiovascular prognosis, asymptomatic atrial fibrillation, randomized trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Clinique Victor Pauchet
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Dec 2024 (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.
Postoperative atrial fibrillation (POAF) occurs in approximately 20% of patients following thoracic surgery. Early diagnosis is essential to prevent complications such as heart failure, stroke, myocardial infarction, and increased mortality. Smartwatches equipped with single-lead ECG capabilities and algorithms to detect asymptomatic atrial fibrillation (AF) offer a potential solution. This study aims to evaluate the effectiveness of smartwatches in detecting POAF compared to standard care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartwatch group | Experimental | Other: smartwatch, Other: ECGExperimental intervention using smartwatches for rhythm monitoring. |
| Control group | Active comparator | Other: ECGStandard care without smartwatch monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (>18 years old).
- Patients undergoing major thoracic surgery with one-lung ventilation within the past 48 hours.
- Scheduled pneumonectomy or lobectomy.
- Admission to a conventional surgical unit postoperatively.
- Ability to perform single-lead ECG using a smartwatch.
Key exclusion criteria (8 listed)
- History of atrial fibrillation.
- Requirement for telemetry for AV block or tachyarrhythmias (>140 bpm).
- Dependency on a pacemaker.
- Participation in another interventional clinical trial affecting POAF incidence.
- Mediastinal, pleural, or chest wall surgery.
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 |
|---|---|---|
| smartwatchPatients in the smartwatch group will undergo rhythm monitoring with a smartwatch | Other | Smartwatch group |
| ECGDetected POAF episodes will be confirmed via a 12-lead ECG | Other | Control group, Smartwatch group |
Primary outcome
the incidence of POAF
Time frame: at day 7
the incidence of POAF within seven days after scheduled thoracic surgery.
8 secondary outcomes
Rate of asymptomatic POAF
Time frame: at day 7
Cardiovascular prognosis
Time frame: at day 3
Cardiovascular prognosis
Time frame: at 6 months
Feasibility of rhythm monitoring with a smartwatch
Time frame: at day 7
Recurrence of AF
Time frame: at 3 months
Recurrence of AF
Time frame: at 6 months
management of AF
Time frame: at 3 months
management of AF
Time frame: at 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 12 Jun 2025.
- Derived from this study: PubMed 40204329Huette P, Beyls C, Diouf M, Ibrahima A, Haye G, Guilbart M, Lefebvre T, Bayart G, Lhotellier F, Radji M, Walczak KA, Caboche M, De Dominicis F, Georges O, Berna P, Merlusca G, Hermida A, Traulle S, Dupont H, Mahjoub Y, Abou-Arab O; THOFAWATCH Study Group. Study protocol: diagnosis of atrial fibrillation in postoperative thoracic surgery using a smartwatch, an open-label randomised controlled study (THOFAWATCH trial). BMJ Open. 2025 Apr 9;15(4):e097765. doi: 10.1136/bmjopen-2024-097765.
- 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.
Pierre Huette, MD principal investigator
Centre Hospitalier Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smartwatch and ECG in people with Postoperative Atrial Fibrillation and Thoracic 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 8 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 12 Jun 2025. 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 Pierre Huette, MD (33322088371, Huette.pierre@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of POAF (time frame: at day 7). 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 NCT06724718, 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 12 Jun 2025.