Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06724718

Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-06-12

302

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier Universitaire, Amiens

Lead Sponsor

C

Clinique Victor Pauchet

Collaborating Sponsor

AI-Summary

What this Trial Is About

Postoperative atrial fibrillation (POAF) affects about 20% of patients after thoracic surgery and can lead to serious complications like heart failure, stroke, and increased risk of death. Researchers are studying how well smartwatches with single-lead ECG and detection algorithms can identify POAF compared to standard care. The goal is to find early diagnosis methods to improve patient outcomes after surgery. Participants are randomly assigned to one of two groups: the smartwatch group, where they use a smartwatch for rhythm monitoring, or the control group, which receives standard care without smartwatch monitoring. If POAF episodes are detected, they are confirmed with a 12-lead ECG. The study evaluates the incidence of POAF at day 7 and other outcomes such as cardiovascular prognosis and AF management up to 6 months. During the study, participants will be monitored for heart rhythm using the smartwatch or standard methods. Researchers will assess how often POAF occurs by day 7, the rate of asymptomatic POAF, and cardiovascular health at day 3 and 6 months. They will also evaluate the feasibility of smartwatch monitoring and track recurrence and management of AF at 3 and 6 months. The study starts in June 2025 and continues until December 2027.

CONDITIONS

Brief Title

Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (>18 years old)
  • Patients who had major thoracic surgery with one-lung ventilation within the past 48 hours
  • Scheduled for pneumonectomy or lobectomy surgery
  • Admitted to a conventional surgical unit after surgery
  • Able to perform single-lead ECG using a smartwatch
  • Covered by a social security system
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • History of atrial fibrillation
  • Need for telemetry for AV block or tachyarrhythmias (heart rate >140 bpm)
  • Dependence 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
  • Pregnancy
  • Under guardianship or similar legal protection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 7 days

Participants in the smartwatch group undergo rhythm monitoring using a smartwatch after thoracic surgery, while the control group receives standard care without smartwatch monitoring.

Daily monitoring visits or assessments for 7 days

Follow-up

Duration - Up to 6 months

Participants are followed up to assess cardiovascular prognosis and recurrence or management of atrial fibrillation after surgery.

Visits at 3 months and 6 months post-surgery

Trial Site Locations

Total: 1 location

1

Centre hospitalier Amiens

Amiens, France, 80054

Actively Recruiting

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Research Team

P

Pierre Huette, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

Study protocol: diagnosis of atrial fibrillation in postoperative thoracic surgery using a smartwatch, an open-label randomised controlled study (THOFAWATCH trial).

Pierre Huette, Christophe Beyls, Momar Diouf...

https://pubmed.ncbi.nlm.nih.gov/40204329