Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch (THO-FA-WATCH)

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Postoperative Atrial Fibrillation; Smartwatches; Asymptomatic Atrial Fibrillation; Randomized Trial; Cardiovascular Prognosis; Rhythm Monitoring; Thoracic Surgery

Treatments: Other: smartwatch; Other: ECG

Study type: Interventional

Funder types: Other

Identifiers

NCT06724718

PI2023_843_0139

Details and patient eligibility

About

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.

Enrollment: 302 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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302 participants in 2 patient groups

Smartwatch group

Experimental group

Description:

Experimental intervention using smartwatches for rhythm monitoring.

Treatment:

Other: ECG

Other: smartwatch

Control group

Active Comparator group

Description:

Standard care without smartwatch monitoring

Treatment:

Other: ECG