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

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.