Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • smartwatch

    Other intervention

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

  • ECG

    Other intervention

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

Treatment groups

302 Participants
are divided into 2 treatment groups
Group A: Smartwatch groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

the incidence of POAF

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

Time frame
at day 7

Secondary outcomes

1

Rate of asymptomatic POAF

Rate of asymptomatic POAF, evaluated using the EHRA symptom score

Time frame
at day 7
2

Cardiovascular prognosis

Cardiovascular prognosis assessed through a composite outcome (MACE)

Time frame
at day 3
3

Cardiovascular prognosis

Cardiovascular prognosis assessed through a composite outcome (MACE)

Time frame
at 6 months
4

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.

Time frame
at day 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire, Amiens

Lead sponsor

Clinique Victor Pauchet

Collaborator