Remote Design of a Smartphone and Wearable Detected Atrial Arrhythmia in Older Adults Case Finding Study: Smart in OAC - AFNET 9

Larissa Fabritz, D Connolly, E Czarnecki, D Dudek, A Zlahoda-Huzior, E Guasch, D Haase, T Huebner, K Jolly, P Kirchhof, Ulrich Schotten, Antonia Zapf, Renate B Schnabel, Larissa Fabritz, D Connolly, E Czarnecki, D Dudek, A Zlahoda-Huzior, E Guasch, D Haase, T Huebner, K Jolly, P Kirchhof, Ulrich Schotten, Antonia Zapf, Renate B Schnabel

Abstract

Introduction: Screening for atrial fibrillation and timely initiation of oral anticoagulation, rhythm management, and treatment of concomitant cardiovascular conditions can improve outcomes in high-risk populations. Whether wearables can facilitate screening in older adults is not known.

Methods and analyses: The multicenter, international, investigator-initiated, single-arm case-finding Smartphone and wearable detected atrial arrhythmia in older adults case finding study (Smart in OAC - AFNET 9) evaluates the diagnostic yield of a validated, cloud-based analysis algorithm detecting atrial arrhythmias via a signal acquired by a smartphone-coupled wristband monitoring system in older adults. Unselected participants aged ≥65 years without known atrial fibrillation and not receiving oral anticoagulation are enrolled in three European countries. Participants undergo continuous pulse monitoring using a wristband with a photo plethysmography (PPG) sensor and a telecare analytic service. Participants with PPG-detected atrial arrhythmias will be offered ECG loop monitoring. The study has a virtual design with digital consent and teleconsultations, whilst including hybrid solutions. Primary outcome is the proportion of older adults with newly detected atrial arrhythmias (NCT04579159).

Discussion: Smart in OAC - AFNET 9 will provide information on wearable-based screening for PPG-detected atrial arrhythmias in Europe and provide an estimate of the prevalence of atrial arrhythmias in an unselected population of older adults.

Keywords: atrial fibrillation; digital cardiology; digital consent; photo plethysmography; screening; stroke; telemedicine; wearable.

Conflict of interest statement

LF has received institutional research grants and non-financial support from European Union, British Heart Foundation, Medical Research Council (United Kingdom), several biomedical companies and previously DFG. The Institute of Cardiovascular Research, University of Birmingham, has received an Accelerator Award by the British Heart Foundation AA/18/2/34218. LF and PK are listed as inventor of two patents held by University of Birmingham (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783). US received consultancy fees or honoraria from Università della Svizzera Italiana (USI, Switzerland), Roche Diagnostics (Switzerland), EP Solutions Inc. (Switzerland), Johnson & Johnson Medical Limited, (United Kingdom). US is co-founder and shareholder of YourRhythmics BV, a spin-off company of the University Maastricht. RS has received speaker fees from BMS/Pfizer. PK receives research support for basic, translational, and clinical research projects from European Union, British Heart Foundation, Leducq Foundation, Medical Research Council (United Kingdom), and German Centre for Cardiovascular Research, from several drug and device companies active in atrial fibrillation, and has received honoraria from several such companies in the past, but not in the last three years. PK is listed as inventor on two patents held by University of Birmingham (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783). DC receives consulting fees from Bayer, Boehringer Ingleheim, Daiichi-Sankyo and Pfizer. TH is the founder and CEO of Preventicus. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Fabritz, Connolly, Czarnecki, Dudek, Zlahoda-Huzior, Guasch, Haase, Huebner, Jolly, Kirchhof, Schotten, Zapf and Schnabel.

Figures

FIGURE 1
FIGURE 1
Study flow chart.

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Source: PubMed

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