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

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

doi:10.1186/s13063-019-3189-7

Cited by 4 publications

(3 citation statements)

References 27 publications

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“…In this single center, open label, randomized controlled trial, we randomly assigned patients in a 1:1 ratio to a systematic screening strategy using the Zenicor (Medical Systems AB) single-lead handheld ECG recording device vs. a control group with standard clinical care. The study methods and design have been published previously ( 8 ). The study was conducted in accordance with the Declaration of Helsinki and was approved by the regional ethics committee ( ClinicalTrials.gov , ID: NCT03197090, first registration on 23/06/2017).…”

Section: Methodsmentioning

confidence: 99%

Handheld ECG Tracking of in-hOspital Atrial Fibrillation (HECTO-AF): A Randomized Controlled Trial

Mancinetti

Schukraft

Faucherre

et al. 2021

Front. Cardiovasc. Med.

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Background: Atrial fibrillation (AF) is frequent and causes substantial morbidity through AF-related strokes. Given the increasing prevalence of AF, screening methods are of interest given the potential to initiate timely appropriate anticoagulation.Aims: The HECTO-AF trial aims to determine the efficacy of AF screening with a single-lead electrocardiogram (ECG) handheld device in naïve in-hospital patients.Methods: The HECTO-AF is a single-center, open label, randomized controlled trial. Patients admitted to the general internal medicine ward of the University and Hospital Fribourg without previous diagnosis of AF were invited to participate in a screening program with a 1:1 allocation to either the screening group with intermittent single-lead handheld ECG recordings vs. a control group undergoing detection of AF as per routine clinical practice. The primary outcome was the prevalence of newly diagnosed AF during the hospital stay. Enrolment was terminated for poor patient recruitment and apparent futility before a sufficient sample for powered efficacy comparisons was enrolled.Results: A total of 804 patients were included of whom 381 were allocated to the intervention and 423 to the control group. Mean age was 65 ± 16 and 464 (58%) were male. Median CHA2DS2-VASc score was 3 (13% heart failure, 57% hypertension, 19% diabetes mellitus, 14% prior stroke/transient ischemic attack, and 29% arterial disease) and all CHA2DS2-VASc risk factors were equally distributed between groups. The incidence of newly detected AF was 1.4% over a median of 6 hospitalized days. Seven patients (1.8%) were diagnosed with AF in the intervention group vs. 3 (0.7%) in the control group (p = 0.20).Conclusion: There was a trend toward a higher AF detection over a median of 6 hospitalized days in the intervention group, but a definitive conclusion cannot be drawn due to the early termination of the present study. Systematic screening for AF in the hospital setting is resource-consuming, and of uncertain clinical benefit. The interpretation of single-lead handheld ECG is challenging and may result in inaccurate AF diagnosis.Clinical Trial Registration:ClinicalTrials.gov, identifier [NCT03197090].

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Section: Methodsmentioning

confidence: 99%

Handheld ECG Tracking of in-hOspital Atrial Fibrillation (HECTO-AF): A Randomized Controlled Trial

Mancinetti

Schukraft

Faucherre

et al. 2021

Front. Cardiovasc. Med.

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View full text Add to dashboard Cite

show abstract

“…The study methods and design have been published previously. (8) The study was conducted in accordance with the Declaration of Helsinki and was approved by the regional ethics committee (ClinicalTrials.gov, ID: NCT03197090, rst registration on 23/06/2017). All patients provided written, informed consent for participation.…”

Section: Methodsmentioning

confidence: 99%

Handheld ECG Tracking of in-hOspital Atrial Fibrillation (HECTO-AF): A Randomized Controlled Trial

Mancinetti

Schukraft

Faucherre

et al. 2020

Preprint

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Background. Atrial fibrillation (AF) is frequent and causes substantial morbidity through AF-related strokes. Given the increasing prevalence of AF, screening methods are of interest given the potential to initiate timely appropriate anticoagulation. The HECTO-AF trial aims to determine the efficacy of AF screening with a single-lead electrocardiogram (ECG) handheld device in naïve in-hospital patients.Methods. The HECTO-AF is a single-centre, open label, randomized controlled trial. Patients admitted to the general medicine ward of the University and Hospital Fribourg without previous diagnosis of AF were invited to participate in a screening program with a 1:1 allocation to either the screening group with intermittent single-lead handheld ECG recordings vs. a control group undergoing detection of AF as per routine clinical practice. Primary outcome was prevalence of newly diagnosed AF. Enrolment was terminated for poor patient recruitment and apparent futility before a sufficient sample for powered efficacy comparisons was enrolled. Results. A total 804 patients were included of whom 381 were allocated to the intervention and 423 to the control group. Mean age was 65±16 and 464 (58%) were male. Median CHA2DS2-VASc score was 3 (13% heart failure, 57% hypertension, 19% diabetes mellitus, 14% prior stroke/transient ischemic attack, 29% arterial disease) and all CHA2DS2-VASc risk factors were equally distributed between groups. Seven patients (1.8%) were diagnosed with AF in the intervention group versus 3 (0.7%) in the control group (p-value=0.20). Conclusion. There was a trend towards a higher AF detection in the intervention group, but a definitive conclusion cannot be drawn due to the early termination of the present study. Systematic screening for AF in the hospital setting is resource-consuming, and of uncertain clinical benefit. The interpretation of single-lead handheld ECG is challenging and may result in inaccurate AF diagnosis. Trial registration. ClinicalTrials.gov, ID: NCT03197090.

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“…However, the feasibility of recording a 3-lead ECG with the Apple Watch Series 4 was reported in only one case report of two patients with myocardial infarction [ 7 ], a technical report [ 12 ], and three observational studies from a same group of investigators [ 13 , 14 , 15 ]. The other available studies were related to the other capabilities of smart wearables, ranging from screening and diagnostic to treatment functions, using other technologies, namely photoplethysmography (PPG) [ 4 , 5 , 16 , 17 , 18 , 19 , 20 , 21 ].…”

Section: Introductionmentioning

confidence: 99%

Feasibility and Reliability of SmartWatch to Obtain 3-Lead Electrocardiogram Recordings

Behzadi

Shamloo

Mouratis

et al. 2020

Sensors

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Some of the recently released smartwatch products feature a single-lead electrocardiogram (ECG) recording capability. The reliability of obtaining 3-lead ECG with smartwatches is yet to be confirmed in a large study. This study aimed to assess the feasibility and reliability of smartwatch to obtain 3-lead ECG recordings, the classical Einthoven ECG leads I-III compared to standard ECG. To record lead I, the watch was worn on the left wrist and the right index finger was placed on the digital crown for 30 s. For lead II, the watch was placed on the lower abdomen and the right index finger was placed on the digital crown for 30 s. For lead III, the same process was repeated with the left index finger. Spearman correlation and Bland-Altman tests were used for data analysis. A total of 300 smartwatch ECG tracings were successfully obtained. ECG waves’ characteristics of all three leads obtained from the smartwatch had a similar duration, amplitude, and polarity compared to standard ECG. The results of this study suggested that the examined smartwatch (Apple Watch Series 4) could obtain 3-lead ECG tracings, including Einthoven leads I, II, and III by placing the smartwatch on the described positions.

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

Cited by 4 publications

References 27 publications

Handheld ECG Tracking of in-hOspital Atrial Fibrillation (HECTO-AF): A Randomized Controlled Trial

Handheld ECG Tracking of in-hOspital Atrial Fibrillation (HECTO-AF): A Randomized Controlled Trial

Handheld ECG Tracking of in-hOspital Atrial Fibrillation (HECTO-AF): A Randomized Controlled Trial

Feasibility and Reliability of SmartWatch to Obtain 3-Lead Electrocardiogram Recordings

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