NCT05573633: FAWATCH

Diagnosis of Postoperative Atrial Fibrillation by a Smartwatch

Recruiting now NA Last updated 24 February 2026

What this trial tests

NA trial testing ECG in Atrial Fibrillation in 324 participants. Currently enrolling.

Timeline

6 October 2022

Primary endpoint
6 October 2027

6 July 2028

Quick facts

Lead sponsor	Centre Hospitalier Universitaire, Amiens
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	324
Start date	6 October 2022
Primary completion	6 October 2027
Estimated completion	6 July 2028
Sites	1 location across France

Drugs / interventions tested

• ECG
• scanwatch

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Cardiac Surgery — all drugs for Cardiac Surgery →

Sponsor

Centre Hospitalier Universitaire, Amiens

Who can join

18 and older, any sex, with Atrial Fibrillation or Cardiac Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.