Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch
NCT ID: NCT06724718
Last Updated: 2025-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
302 participants
INTERVENTIONAL
2025-06-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Smartwatch group
Experimental intervention using smartwatches for rhythm monitoring.
smartwatch
Patients in the smartwatch group will undergo rhythm monitoring with a smartwatch
ECG
Detected POAF episodes will be confirmed via a 12-lead ECG
Control group
Standard care without smartwatch monitoring
ECG
Detected POAF episodes will be confirmed via a 12-lead ECG
Interventions
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smartwatch
Patients in the smartwatch group will undergo rhythm monitoring with a smartwatch
ECG
Detected POAF episodes will be confirmed via a 12-lead ECG
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Clinique Victor Pauchet
OTHER
Centre Hospitalier Universitaire, Amiens
OTHER
Responsible Party
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Principal Investigators
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Pierre Huette, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Amiens
Locations
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Centre hospitalier Amiens
Amiens, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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PI2023_843_0139
Identifier Type: -
Identifier Source: org_study_id
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