A1 Refereed original research article in a scientific journal
Randomized trial of smartphone application and bed sensor for atrial fibrillation detection in high-risk patients
Authors: Lehto, Joonas; Nuotio, Joel; Relander, Arto; Jaakkola, Jussi; Lahdenoja, Olli; Vasankari, Tuija; Anzanpour, Arman; Elnaggar, Ismail; Rekola, Rami; Sandelin, Jonas; Hurnanen, Tero; Airaksinen, Juhani K. E.; Koivisto, Tero; Kiviniemi, Tuomas O.
Publisher: Springer Nature
Publication year: 2026
Journal: Scientific Reports
Article number: 7088
Volume: 16
eISSN: 2045-2322
DOI: https://doi.org/10.1038/s41598-026-38273-5
Publication's open availability at the time of reporting: Open Access
Publication channel's open availability : Open Access publication channel
Web address : https://doi.org/10.1038/s41598-026-38273-5
Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/515606661
Self-archived copy's licence: CC BY NC ND
Self-archived copy's version: Publisher`s PDF
This two-arm single-center exploratory randomized controlled trial evaluated the efficacy of prolonged rhythm monitoring in atrial fibrillation (AF) detection after an invasive cardiac procedure. Altogether 150 patients were enrolled. In the intervention group (IG), a bed sensor (EMFIT QS) and twice-daily smartphone recordings (CardioSignal app) were used, followed by a 12-lead ECG and a continuous three-to-seven-day ECG monitoring if alerts occurred. The control group (CG) received usual care. Overall, 78 patients were assigned to the IG and 72 to CG. During the three-month follow-up, AF was detected in 6/78 (7.7%) patients in the IG and in 0/72 (0.0%) in the CG (absolute risk difference 7.7%, 95% CI 1.8–13.6%, p = 0.029). After exclusion of patients who withdrew before the 3-month follow-up, 33/68 (48.5%) patients had alarms not leading to ECG-verified AF diagnosis, indicating that the current approach, in its present form, is not suitable for routine clinical implementation. Future studies should concentrate on minimizing alarms not leading to AF diagnosis when developing these novel non-ECG-based technologies. ClinicalTrials.gov Identifier: NCT05351775, 2022/04/28.
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Funding information in the publication:
The study received funding within the Electronic Components and Systems for European Leadership Joint Undertaking (ECSEL JU) in collaboration with the European Union’s H2020 Framework Programme (H2020/2014–2020) and National Authorities, under grant agreement H2020-ECSEL-2019-IA-876190, as well as Business Finland. The sponsors had no involvement in the study design, protocol amendments, collection, analysis, or interpretation of the data, report writing, or the decision to submit the paper for publication. The authors had full access to all study data and held final responsibility for the decision to submit the manuscript for publication.
