Handheld ECG Tracking of in-hOspital Atrial Fibrillation The HECTO-AF trial Clinical Study Protocol

Sara Schukraft,Serban Puricel,Daniel Hayoz,Yannick Faucherre,Diego Arroyo,Marco Mancinetti,Stéphane Cook

doi:10.1186/s13063-019-3189-7

Sara Schukraft, Serban Puricel + Show 5 more

Open Access

https://doi.org/10.1186/s13063-019-3189-7

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Abstract

Background/rationaleAtrial fibrillation (AF) is frequent and causes great morbidity in the aging population. While initial events may be symptomatic, many patients have silent AF and are at risk of ischemic embolic complications. Timely detection of asymptomatic patients is paramount. The HECTO-AF trial aims to investigate the efficacy of an electrocardiogram (ECG) handheld device for the detection of AF in patients in hospital without a prior diagnosis of AF.Methods/designThe “Handheld ECG tracking of in-hospital atrial fibrillation” (HECTO-AF) study is a single-center, open-label, randomized controlled trial. The study population consists of all adult patients admitted to a general medicine ward of the University and Hospital of Fribourg throughout the study period. The study will enroll 1600 patients with 1:1 ratio allocation to either the detection group with one-lead handheld ECG recordings twice daily and extra recordings in the case of palpitations, versus a control group undergoing detection of AF as per routine clinical practice. Recordings will be self-performed after dedicated training, and will be independently adjudicated through a specific web-based interface. All enrolled patients will be followed clinically at 1, 2 and 5 years to assess the occurrence of AF, death, non-fatal stroke, systemic embolism, myocardial infarction and bleeding. The primary outcome is incidence of newly detected AF during the hospital stay. Secondary outcomes are incidence of AF, cardiovascular death, stroke, myocardial infarction and bleeding complications at 1, 2 and 5 years.DiscussionHECTO-AF is an independent randomized study aiming to detect the incidence of silent AF in all-comers hospitalized in general medicine wards.Trial registrationClinicalTrials.gov, NCT03197090. Registered on 23 June 2017. Local ethical Committee (CER-VD) registration number: 2017–01594. There are no conflicts of interest to declare.

Highlights

HECTO-Atrial fibrillation (AF) is an independent randomized study aiming to detect the incidence of silent AF in all-comers hospitalized in general medicine wards
The present study aims to determine the incidence of silent AF using a single-lead ECG handheld device in patients hospitalized in the department of general internal medicine of the University and Hospital of Fribourg, Switzerland
The 2016 European Society of Cardiology (ESC) guidelines encourage systematic AF screening programs in at-risk populations [14], which include most patients admitted to general medicine wards, who are older and have several comorbidities

Summary

Discussion

Silent AF is common [17], especially in older patients and those with heart failure [18], and may lead to stroke or death [19, 20]. The 2016 ESC guidelines encourage systematic AF screening programs in at-risk populations [14], which include most patients admitted to general medicine wards, who are older and have several comorbidities. A recent study assessing the performance of handheld ECG devices to detect AF in cardiology and geriatric wards [22] found acceptable sensitivity (81–89%) and specificity (94–97%) compared to standard ECG. Sensitivity and specificity compared to 12-lead ECG are 96% and 92%, respectively [23]. The device has been evaluated for AF screening and has shown higher sensitivity for detection of silent AF compared to conventional 24-h Holter recordings [24, 25].

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