A Photoplethysmography-Based Machine Learning Algorithm for Early Atrial Fibrillation Detection: A Prospective Validation Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSeerlinq s. r. o.

About this trial

This is a prospective study validating a new machine-learning algorithm that detects atrial fibrillation (AF) from photoplethysmography (PPG) signals, developed for integration into the Seerlinq remote monitoring platform. This algorithm builds on the same core PPG signal-processing technology as Seerlinq's HeartCore device, a CE-certified (Class IIb, MDR) device that monitors left ventricular filling pressures in heart failure patients. The algorithm will be validated through internal cross-validation, external validation against an independent cohort with paired PPG-ECG recordings, and validation in a cohort of patients with paroxysmal atrial fibrillation and frequent sinus-AF transitions.

Eligibility criteria

Qualifiers

Adults ≥18 years with a diagnosis of heart failure (HFrEF, HFmrEF, or HFpEF)

12-lead ECG performed to confirm cardiac rhythm classification (AF vs. non-AF)

Disqualifiers

Missing a valid PPG recording

Trial design

Treatments tested in this trial

  • PPG-based AF detection algorithm

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Seerlinq s. r. o.

Lead sponsor

ACADEMY - občianske združenie

Collaborator

Premedix Academy

Collaborator