Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch

Not Applicable

Recruiting

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

• Registration Number: NCT06724718
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-09
• Status Verified: 2025-06
• Study Start: 2025-06-01
• Last Update Submitted: 2025-06-11
• Last Update Posted: 2025-06-12
• Primary Completion: 2027-07
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 302

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the incidence of POAF	at day 7	the incidence of POAF within seven days after scheduled thoracic surgery.

Secondary Outcome Measures

Name	Time	Method
Rate of asymptomatic POAF	at day 7	Rate of asymptomatic POAF, evaluated using the EHRA symptom score
Cardiovascular prognosis	at 6 months	Cardiovascular prognosis assessed through a composite outcome (MACE)
Feasibility of rhythm monitoring with a smartwatch	at day 7	Feasibility of rhythm monitoring with a smartwatch, measured by device usage time and the proportion of successful single-lead ECGs performed.
Recurrence of AF	at 6 months	Recurrence of AF
management of AF	at 6 months	management of AF

Trial Locations

Locations (1)

Centre hospitalier Amiens; 🇫🇷 Amiens, France