CHU Amiens Picardie
Amiens, France
Location status: Recruiting
NCT Number: NCT05573633
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Amiens, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
POAF will be diagnosed with a Withings SM (ScanWatch) by a 1-lead ECG and/or 12-lead ECG.
Time frame: 5 days
The incidence of POAF will be compared between the two arms
Time frame: 5 days
Time frame: At the enrollment in the study (day 0)
Left atrial reservoir strain (LASr), measured by transthoracic echocardiography at discharge from the cardiothoracic intensive care unit to the conventional ward, expressed as a percentage (%), and analyzed for its association with POAF (comparison between patients with and without POAF).
Time frame: 5 days
The feasibility of rhythm monitoring using a smartwatch will be assessed by wear time of the smartwatch during the protocol period
Time frame: 3 months and 6 months after inclusion
Cardiovascular prognosis will be assessed using a composite endpoint of postoperative cardiovascular complications (MACE), defined according to the standards of the European Society of Anaesthesiology (ESA). MACE will be considered present if at least one of the following events occurs: stroke; Myocardial infarction; Digestive ischemia; Unplanned hospitalization for acute right and/or left heart failure decompensation; Resuscitated cardiac arrest and Cardiovascular death.
Unit : Frequency of patients experiencing at least one MACE event (percentage, %).
Time frame: 3 months and 6 months
Percentage of patients with POAF after hospital discharge in both groups (with and without smartwatch), assessed at 3 and 6 months after discharge.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire, Amiens
Other
Diagnosis of Postoperative Atrial Fibrillation After Cardiac Surgery by a Smartwatch: an Open-label Randomized Controlled Trial
Acronym: FAWATCH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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