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NCT Number: NCT06724718

Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier Amiens

Amiens, 80054, France

Location status: Recruiting

Location contact

Christophe Beyls, MD

SUB_INVESTIGATOR

Pierre Huette, MD

CONTACT

[email protected]

33322088371

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smartwatch

Other

Patients in the smartwatch group will undergo rhythm monitoring with a smartwatch

ECG

Other

Detected POAF episodes will be confirmed via a 12-lead ECG

Primary outcomes

  1. the incidence of POAF

    Time frame: at day 7

    the incidence of POAF within seven days after scheduled thoracic surgery.

Secondary outcomes

  1. Rate of asymptomatic POAF

    Time frame: at day 7

    Rate of asymptomatic POAF, evaluated using the EHRA symptom score

  2. Cardiovascular prognosis

    Time frame: at day 3

    Cardiovascular prognosis assessed through a composite outcome (MACE)

  3. Cardiovascular prognosis

    Time frame: at 6 months

    Cardiovascular prognosis assessed through a composite outcome (MACE)

  4. Feasibility of rhythm monitoring with a smartwatch

    Time frame: at day 7

    Feasibility of rhythm monitoring with a smartwatch, measured by device usage time and the proportion of successful single-lead ECGs performed.

  5. Recurrence of AF

    Time frame: at 3 months

    Recurrence of AF

  6. Recurrence of AF

    Time frame: at 6 months

    Recurrence of AF

  7. management of AF

    Time frame: at 3 months

    management of AF

  8. management of AF

    Time frame: at 6 months

    management of AF

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre Huette, MD

CONTACT

[email protected]

33322088371

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Clinique Victor Pauchet

Registry information

Acronym: THO-FA-WATCH

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2024
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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