Diagnosis of Postoperative Atrial Fibrillation by a Smartwatch

Atrial Fibrillation Clinical Trial

— FAWATCH  

Official title:

Diagnosis of Postoperative Atrial Fibrillation After Cardiac Surgery by a Smartwatch: an Open-label Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05573633
• Other study ID #: PI2021_843_0228
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2022
• Est. completion date: April 2025

Study information

• Verified date: October 2022
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Christophe Beyls, MD
• Phone: 03 22 08 78 66
• Email: beyls.christophe[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 358
• Est. completion date: April 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiac Surgery

Intervention

Procedure:
• ECG
the POAF will be diagnosed using a 12-lead ECG and according to the usual monitoring protocols for patients in the cardiac surgery department of Amiens University Hospital.
• scanwatch
POAF will be diagnosed with a Withings SM (ScanWatch). FAPO diagnosed by the SW will have to be confirmed by a 12-lead ECG.

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of POAF incidence between both groups	The incidence of POAF will be compared between the two arms	5 days
Secondary	percentage of asymptomatic PAOF in the SW arm		5 days