RecruitingNot ApplicableNCT05573633

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


Sponsor

Centre Hospitalier Universitaire, Amiens

Enrollment

324 participants

Start Date

Oct 6, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether a smartwatch can reliably detect an irregular heartbeat called atrial fibrillation (AF) in patients who have recently had open-heart surgery. AF is a common complication after cardiac surgery, and early detection could improve outcomes. **You may be eligible if...** - You are an adult over 18 - You have recently had open-heart surgery (within the past 96 hours) at Amiens University Hospital in France - You have the physical and mental ability to perform a simple ECG reading on a smartwatch **You may NOT be eligible if...** - You have a history of atrial fibrillation - You currently need continuous heart rhythm monitoring in intensive care - You have an external pacemaker attached - You are under 18 or cannot provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREECG

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.

PROCEDUREscanwatch

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


Locations(1)

CHU Amiens Picardie

Amiens, France

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NCT05573633


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