Using a smartwatch to diagnose postoperative atrial fibrillation
Diagnosis of Postoperative Atrial Fibrillation After Cardiac Surgery by a Smartwatch: an Open-label Randomized Controlled Trial
NA · Centre Hospitalier Universitaire, Amiens · NCT05573633
This study is testing whether a smartwatch can help doctors find out if patients who just had heart surgery develop a common heart rhythm problem called atrial fibrillation while they are still in the hospital.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens (other) |
| Locations | 1 site (Amiens) |
| Trial ID | NCT05573633 on ClinicalTrials.gov |
What this trial studies
This study aims to diagnose postoperative atrial fibrillation (POAF) in patients who have recently undergone on-pump cardiac surgery using a smartwatch equipped with ECG capabilities. Given that POAF can often be asymptomatic and occurs primarily during hospitalization, the smartwatch will provide continuous heart rate monitoring to detect episodes of POAF early. The study will involve adult patients hospitalized at Amiens University Hospital, who will be monitored for signs of atrial fibrillation within 96 hours post-surgery. The goal is to improve early detection and management of POAF, potentially reducing associated risks and complications.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have undergone recent on-pump cardiac surgery at Amiens University Hospital.
Not a fit: Patients with a history of atrial fibrillation or those requiring intensive rhythmic monitoring due to other cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier diagnosis and management of postoperative atrial fibrillation, reducing the risk of serious complications.
How similar studies have performed: While the use of smartwatches for health monitoring is gaining traction, this specific approach to diagnosing POAF post-surgery is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient (\>18 years old) * The patient was hospitalized at Amiens University Hospital for on-pump cardiac surgery. * The patient has had a recent on-pump cardiac surgery (\< 96h) * Patient with the motor and cognitive abilities to perform a 1-lead ECG with the smartwatch * The patient was transferred to the cardiac surgery department of Amiens University Hospital. * The beneficiary of a social security plan * Signature of the consent to participate in the study Exclusion Criteria: * History of AF * Need for rhythmic monitoring by telemetry in cardiac intensive care for atrioventricular block and rapid supra and ventricular rhythm disorder (\>140 bpm). * An external pacemaker connected to epicardial electrodes depends on ventricular and atrial pacing. * Patients already included in an interventional clinical research protocol may alter the incidence of POAF. * Pregnant woman
Where this trial is running
Amiens
- CHU Amiens Picardie — Amiens, France (RECRUITING)
Study contacts
- Study coordinator: Christophe Beyls, MD
- Email: beyls.christophe@chu-amiens.fr
- Phone: 03 22 08 78 66
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, Cardiac Surgery, smartwatch, perioperative atrial fibrillation, cardiac surgery