Evaluating Smartwatch Monitoring to Detect Atrial Fibrillation After Major Thoracic Surgery
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-06-12
302
Participants Needed
1
Research Sites
21 weeks
Total Duration
AI-Summary
What this Trial Is About
Postoperative atrial fibrillation POAF affects about 20% of patients after thoracic surgery and can lead to serious complications like heart failure, stroke, and increased risk of death. Researchers are studying how well smartwatches with single-lead ECG and detection algorithms can identify POAF compared to standard care. The goal is to find early diagnosis methods to improve patient outcomes after surgery.
Participants are randomly assigned to one of two groups the smartwatch group, where they use a smartwatch for rhythm monitoring, or the control group, which receives standard care without smartwatch monitoring. If POAF episodes are detected, they are confirmed with a 12-lead ECG. The study evaluates the incidence of POAF at day 7 and other outcomes such as cardiovascular prognosis and AF management up to 6 months.
During the study, participants will be monitored for heart rhythm using the smartwatch or standard methods. Researchers will assess how often POAF occurs by day 7, the rate of asymptomatic POAF, and cardiovascular health at day 3 and 6 months. They will also evaluate the feasibility of smartwatch monitoring and track recurrence and management of AF at 3 and 6 months. The study starts in June 2025 and continues until December 2027.
CONDITIONS
Brief Title
Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch
Research Team
P
Pierre Huette, MD
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Patients who had major thoracic surgery with one-lung ventilation within the past 48 hours
Scheduled for pneumonectomy or lobectomy surgery
Admitted to a conventional surgical unit after surgery
Able to perform single-lead ECG using a smartwatch
Covered by a social security system
Signed informed consent
You will not qualify if you...
History of atrial fibrillation
Need for telemetry for AV block or tachyarrhythmias (heart rate >140 bpm)
Dependence 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
Pregnancy
Under guardianship or similar legal protection
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 7 days
Participants in the smartwatch group undergo rhythm monitoring using a smartwatch after thoracic surgery, while the control group receives standard care without smartwatch monitoring.
Daily monitoring visits or assessments for 7 days
Follow-up
Duration - Up to 6 months
Participants are followed up to assess cardiovascular prognosis and recurrence or management of atrial fibrillation after surgery.
Visits at 3 months and 6 months post-surgery
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Published Research Related To This Trial
Study protocol: diagnosis of atrial fibrillation in postoperative thoracic surgery using a smartwatch, an open-label randomised controlled study (THOFAWATCH trial).