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

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

Abstract

Background/rationale: Atrial 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/design: The "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.

Discussion: HECTO-AF is an independent randomized study aiming to detect the incidence of silent AF in all-comers hospitalized in general medicine wards.

Trial registration: ClinicalTrials.gov, NCT03197090 . Registered on 23 June 2017. Local ethical Committee (CER-VD) registration number: 2017-01594. There are no conflicts of interest to declare.

Keywords: Atrial fibrillation; Atrial fibrillation screening; ECG handheld device; General medicine.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the local ethics committee of Vaud (Switzerland, CER-VD 2017–01594).

Consent for publication

All authors consented to publication.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flowchart. Participants are randomized 1:1 to either handheld single-lead electrocardiogram (ECG) (Zenicor) screening or the control group
Fig. 2
Fig. 2
Electrocardiogram (ECG) recording with Zenicor, showing atrial fibrillation (AF) (a) and sinus rhythm (b)
Fig. 3
Fig. 3
Timetable of investigations, interventions and assessments. ECG, electrocardiogram; FU, follow up; y, year. Primary outcome: new-onset atrial fibrillation (AF). Secondary outcome: incidence of ischemic stroke or systemic embolism, myocardial infarction, cardiovascular death or heart failure

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