NCT05573633Recruiting
Diagnosis of Postoperative Atrial Fibrillation by a Smartwatch
Diagnosis of Postoperative Atrial Fibrillation After Cardiac Surgery by a Smartwatch: an Open-label Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
The incidence of postoperative atrial fibrillation (POAF) after on-pump cardiac surgery remains high, at around 30%. POAF increases the risk of cardiac decompensation, stroke, acute myocardial infarction, and death, resulting in increased morbidity and mortality, hospital length of stay, and cost of patient management. Episodes of POAF are usually paroxysmal and asymptomatic, increasing the risk of developing permanent AF at five years by 4 to 5 times. POAF occurs between 3 and 4 days after cardiac surgery, mainly when the patient is hospitalized in a surgical ward without heart rate monitoring as opposed to critical care, where the patient benefits from continuous rhythmic monitoring. The diagnosis of POAF is therefore made with the help of a 12-lead electrocardiogram (ECG) when the patient presents clinical symptoms and when the medical staff notes a significant variation in heart rate. However, many patients with episodes of asymptomatic POAF have a higher risk of stroke and mortality than those with symptomatic POAF. Faced with this public health problem, the development of tools for diagnosing AF is in full swing, mainly the marketing of smartwatches (SWs) that allow for the performance of 1-lead ECG. SW is also equipped with algorithms to analyze heart rate variability and diagnose asymptomatic atrial fibrillation (AF) episodes. The European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) recommend the use of smartwatches to detect AF, in particular, to reduce the economic impact of AF. The aim of the study is to diagnose POAF within the first five days after patient discharge from the critical care unit for the cardiac surgery department.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 324 (estimated)
- First submitted
- 6 Oct 2022
- Start date
- 6 Oct 2022
- Primary completion date
- 6 Oct 2027
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Diseases
- Atrial fibrillation
- NCT number
- NCT05573633
What you commit to
- Study type: Interventional
- Planned participants: 324
- From 6 Oct 2022 to the primary completion date, 6 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Amiens Picardie Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.