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

OAC – AFNET 9 Investigators

doi:10.3389/fcvm.2022.839202

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

OAC – AFNET 9 Investigators

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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.

Original language	English
Article number	839202
Number of pages	7
Journal	Frontiers in cardiovascular medicine
Volume	9
DOIs	https://doi.org/10.3389/fcvm.2022.839202
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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10.3389/fcvm.2022.839202Licence: Creative Commons: Attribution (CC BY)

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MAESTRIA: Machine Learning Artificial Intelligence Early Detection Stroke Atrial Fibrillation
Kirchhof, P., Gkoutos, G. & Fabritz, L.
European Commission
1/03/21 → 28/02/26
Project: EU
Defining clusters of patients with atrial fibrillation at risk of heart failure and death
Kirchhof, P. & Gkoutos, G.
British Heart Foundation
1/07/20 → 30/06/21
Project: Research
Impact of chronic intermittent hypoxia on atrial resting membrane potential and Na 1.5 channel function: A new mechanism for causing atrial fibrillation
Kirchhof, P. & Holmes, A.
British Heart Foundation
1/10/17 → 18/07/21
Project: Research
H2020_COLLAB(IMI-JU)_BIGDATA@HEART
Kotecha, D. & Kirchhof, P.
European Commission
1/03/17 → 28/02/23
Project: Research
H2020_COLLAB_CATCH ME_(LEAD)
Kirchhof, P., Fabritz, L., Hemming, K. & Deeks, J.
European Commission
1/05/15 → 30/04/19
Project: EU

Cite this

@article{90127a97874e4278837b002e5cf3561f,

title = "Remote Design of a Smartphone and Wearable Detected Atrial Arrhythmia in Older Adults Case Finding Study: Smart in OAC – AFNET 9",

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, screening, wearable, digital consent, stroke, telemedicine, digital cardiology, photo plethysmography",

author = "{OAC – AFNET 9 Investigators} and L. Fabritz and D. Connolly and E. Czarnecki and D. Dudek and A. Zlahoda-Huzior and E. Guasch and D. Haase and T. Huebner and K. Jolly and P. Kirchhof and U. Schotten and A. Zapf and R.B. Schnabel",

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{\textquoteright}s Horizon 2020 Research and Innovation Programme (grant agreement Number 648131), from the European Union{\textquoteright}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.",

year = "2022",

month = mar,

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doi = "10.3389/fcvm.2022.839202",

language = "English",

volume = "9",

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AU - OAC – AFNET 9 Investigators

AU - Fabritz, L.

AU - Connolly, D.

AU - Czarnecki, E.

AU - Dudek, D.

AU - Zlahoda-Huzior, A.

AU - Guasch, E.

AU - Haase, D.

AU - Huebner, T.

AU - Jolly, K.

AU - Kirchhof, P.

AU - Schotten, U.

AU - Zapf, A.

AU - Schnabel, R.B.

N1 - 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.

PY - 2022/3/21

Y1 - 2022/3/21

N2 - 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.

AB - 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.

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KW - screening

KW - wearable

KW - digital consent

KW - stroke

KW - telemedicine

KW - digital cardiology

KW - photo plethysmography

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DO - 10.3389/fcvm.2022.839202

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

Abstract

Bibliographical note

Keywords

Access to Document

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Projects

MAESTRIA: Machine Learning Artificial Intelligence Early Detection Stroke Atrial Fibrillation

Defining clusters of patients with atrial fibrillation at risk of heart failure and death

Impact of chronic intermittent hypoxia on atrial resting membrane potential and Na 1.5 channel function: A new mechanism for causing atrial fibrillation

H2020_COLLAB(IMI-JU)_BIGDATA@HEART

H2020_COLLAB_CATCH ME_(LEAD)

Cite this