Diagnosis of Postoperative Atrial Fibrillation by a Smartwatch

NCT05573633 | Recruiting

• 1 other identifier: PI2021_843_0228
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation; Cardiac Surgery

Keywords

smartwatch; Atrial Fibrillation; perioperative atrial fibrillation; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Variation of POAF incidence between both groups

  The incidence of POAF will be compared between the two arms

  5 days

Secondary Outcomes (5)

• percentage of asymptomatic POAF in the SW arm

  5 days

• Association between POAF and left atrial reservoir strain

  At the enrollment in the study (day 0)

• Feasibility of rhythm monitoring using a smartwatch

  5 days

• Cardiovascular prognosis assessed by the occurrence of major adverse cardiovascular events (MACE)

  3 months and 6 months after inclusion

• Percentage of patients POAF after hospital discharge.

  3 months and 6 months

Study Arms (2)

smartwatches group

EXPERIMENTAL

Procedure: scanwatch

no smartwatche group

ACTIVE COMPARATOR

Procedure: ECG

Interventions

ECG PROCEDURE

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.

no smartwatche group

scanwatch PROCEDURE

POAF will be diagnosed with a Withings SM (ScanWatch) by a 1-lead ECG and/or 12-lead ECG.

smartwatches group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christophe Beyls, MD

CONTACT

03 22 08 78 66; beyls.christophe@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 10, 2022
• Study Start: October 6, 2022
• Primary Completion (Estimated): October 6, 2027
• Study Completion (Estimated): July 6, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)