Projects per year
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.
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.
Original language | English |
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Article number | 839202 |
Number of pages | 7 |
Journal | Frontiers in cardiovascular medicine |
Volume | 9 |
DOIs | |
Publication status | Published - 21 Mar 2022 |
Bibliographical note
Funding:The design of this investigator-initiated trial was developed by the authors and AFNET. Sponsor of the trial is AFNET (www.af-net.eu). Financial support is provided from Daiichi Sankyo Europe to AFNET. Preventicus provides the cloud based analytic service Preventicus Heartbeats for analyzing the PPG data and screen for AA; plus the comprehensive IT backbone: Preventicus Telecare (platform for verification and consolidation of abnormal PPG and ECG data), Preventicus Carenet (platform for the study centers to perform the fortnightly ECG service) and Preventicus Caresafe (platform for the study centers to manage the digital enrollment modalities). The wearable technology including the smartphone app, connected to Preventicus IT, is distributed by Corsano/MMT. The ECG loop devices, embedded into Preventicus IT, are made available by the manufacturer Getemed Medizin- und Informationstechnik. LF, PK, and US had received funding from EU Horizon 2020 CATCH ME (grant agreement number 633196), MAESTRIA (grant agreement number 965286). LF and PK had received funding Accelerator Award by the British Heart Foundation AA/18/2/34218. US received funding from the Dutch Heart Foundation (CVON2014-09, RACE V Reappraisal of Atrial Fibrillation: Interaction between hyperCoagulability, Electrical remodeling, and Vascular Destabilisation in the Progression of AF). RS had received funding from the European Research Council (ERC) under the European Union’s Horizon 2020 Research and Innovation Programme (grant agreement Number 648131), from the European Union’s Horizon 2020 Research and Innovation Programme (grant agreement Number 847770 (AFFECT-EU)) and German Center for Cardiovascular Research (DZHK e.V.) (81Z1710103), German Ministry of Research and Education (BMBF 01ZX1408A) and ERACoSysMed3 (031L0239). KJ was part funded by the National Institute for Health Research (NIHR) Applied Research Collaboration West Midlands. PK was partially supported by European Union BigData@Heart (grant agreement EU IMI 116074), AFFECT-AF (grant agreement 847770), and MAESTRIA (grant agreement 965286), British Heart Foundation (PG/17/30/32961; PG/20/22/35093; and AA/18/2/34218), German Centre for Cardiovascular Research supported by the German Ministry of Education and Research (DZHK), and Leducq Foundation.
Keywords
- atrial fibrillation
- screening
- wearable
- digital consent
- stroke
- telemedicine
- digital cardiology
- photo plethysmography
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