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. 2025 Sep 16:S1547-5271(25)02741-9.
doi: 10.1016/j.hrthm.2025.07.060. Online ahead of print.

PPG-based smartphone application vs usual care for atrial fibrillation screening: A European multicenter randomized trial

Jakob Johannes Reichl  1 , Khaled Abdel Hamid  2 , Thilo Burkard  3 , Annina Salome Vischer  4 , Caroline Guzman  4 , Dariusz Dudek  5 , Artur Pawlik  5 , Bela Merkely  6 , Janos Marcell László  6 , Athanasios J Manolis  7 , Manolis S Kallistratos  7 , Dominik Linz  8 , Markus Dörr  9 , Christine Bahr  10 , Branko Belesin  11 , Thomas Hübner  12 , Nicole König  12 , Diana Piper  12 , Jens Eckstein  13
Affiliations
Free article

PPG-based smartphone application vs usual care for atrial fibrillation screening: A European multicenter randomized trial

Jakob Johannes Reichl et al. Heart Rhythm. .
Free article

Abstract

Background: Atrial fibrillation (AF) is the most frequent arrhythmia worldwide and a major cause of ischemic stroke. Screening tools are becoming increasingly popular to detect AF for stroke prevention, yet data from randomized trials are lacking.

Objective: The purpose of this study was to analyze AF detection rates using a smartphone application with early intervention (intervention group) compared with no intervention (sham group).

Methods: This is an international, multicenter, prospective, randomized, sham-controlled, double-blinded trial conducted between October 2019 and May 2024. Patients with no prior AF were randomized 1:1 to an intervention group or a sham group. The study application used the smartphone camera to generate photoplethysmography signals. If an arrhythmia was detected, patients in the intervention group received a notification and a 7-day patch electrocardiogram to confirm AF.

Results: A total of 1021 patients from 8 centers were randomized. The mean CHA2DS2-VASc score was 3.4 ± 0.92 in the intervention group and 3.5 ± 1.02 in the sham group. Arrhythmia was detected in 32 (3.1%) cases: 20 (3.9%) in the intervention group and 12 (2.4%) in the sham group. AF was diagnosed in 13 (1.3%) patients. AF detection rates were numerically higher in the intervention group (10 [1.9%] vs 3 [0.5%]; P = .094), especially in cases of asymptomatic AF (4 [0.8%] vs 0 [0%]; P = .13). There was no difference in the rate of stroke, transient ischemic attack, or systemic embolism after 6 months.

Conclusion: In this multicenter trial, application usage in combination with early intervention did not significantly increase overall AF detection rates. However, asymptomatic AF detection was numerically higher in the intervention group, aligning with current guidelines that recommend photoplethysmography-based devices for AF screening.

Keywords: AF Screening; Atrial fibrillation; Screening; Stroke; Stroke prevention; Wearables.

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Conflict of interest statement

Disclosures Dr Hübner is the founder and CEO of Preventicus. Dr König and Dr Piper are employees of Preventicus. Dr Eckstein and Dr Dörr each holds 0.5% virtual shares of Preventicus. Dr Burkard received grants from the Swiss National Science Foundation, Cardiovascular Research Foundation Basel, AstraZeneca, Daiichi Sankyo, Medtronic, Roche Diagnostics, Novartis, Menarini, Sanofi, Novo Nordisk, and Collabree (outside the submitted work) and lecture and/or travel fees paid to institution by Servier, Medtronic, Sanofi, Novartis, Novo Nordisk, and Daiichi Sankyo (outside the submitted work). Preventicus had no role in the analysis of all data acquired for this study. All other authors confirm that they do not have any conflicts of interest regarding this trial and manuscript.

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