Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: smartwatch, ECG.
- Who it may be relevant to
- Registry conditions: Postoperative Atrial Fibrillation, Thoracic Surgery, Smartwatches, Rhythm Monitoring. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other smartwatch
Patients in the smartwatch group will undergo rhythm monitoring with a smartwatch - Other ECG
Detected POAF episodes will be confirmed via a 12-lead ECG
Primary outcome measures
- the incidence of POAF [Time frame: at day 7]
Secondary outcome measures (8)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Centre hospitalier Amiens — Amiens
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 PMID 40204329
Identifiers
NCT: NCT06724718 · PI2023_843_0139