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

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Surgery; Postoperative Atrial Fibrillation; Cardiovascular Prognosis; Randomized Trial; Smartwatches; Rhythm Monitoring; Asymptomatic Atrial Fibrillation
• Intervention / Treatment: Other: smartwatch; Other: ECG

• Study Type: Interventional
• Enrollment (Estimated): 302
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre Huette, MD; Phone Number: 33322088371; Email: Huette.pierre@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • Centre hospitalier Amiens
    • Sub-Investigator: Christophe Beyls, MD
    • Contact: Pierre Huette, MD; Phone Number: 33322088371; Email: Huette.pierre@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smartwatch group; Experimental intervention using smartwatches for rhythm monitoring.	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
Active Comparator: Control group; Standard care without smartwatch monitoring	Other: ECG; Detected POAF episodes will be confirmed via a 12-lead ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of POAF	the incidence of POAF within seven days after scheduled thoracic surgery.	at day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of asymptomatic POAF	Rate of asymptomatic POAF, evaluated using the EHRA symptom score	at day 7
Cardiovascular prognosis	Cardiovascular prognosis assessed through a composite outcome (MACE)	at day 3
Cardiovascular prognosis	Cardiovascular prognosis assessed through a composite outcome (MACE)	at 6 months
Feasibility of rhythm monitoring with a smartwatch	Feasibility of rhythm monitoring with a smartwatch, measured by device usage time and the proportion of successful single-lead ECGs performed.	at day 7
Recurrence of AF	Recurrence of AF	at 3 months
Recurrence of AF	Recurrence of AF	at 6 months
management of AF	management of AF	at 3 months
management of AF	management of AF	at 6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Clinique Victor Pauchet
• Investigators: Principal Investigator: Pierre Huette, MD, Centre hospitalier Amiens

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: randomized trial; thoracic surgery; Postoperative atrial fibrillation; cardiovascular prognosis; smartwatches; rhythm monitoring; asymptomatic atrial fibrillation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: PI2023_843_0139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No