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RECRUITING
NCT07749183

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

Sponsor: Seerlinq s. r. o.

View on ClinicalTrials.gov

Summary

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.

Official title: Prospective Validation of a Machine-Learning Algorithm Using Photoplethysmography Signals for Early Detection of Atrial Fibrillation During Remote Telemonitoring

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2025-10-01

Completion Date

2026-11

Last Updated

2026-08-06

Healthy Volunteers

No

Interventions

OTHER

PPG-based AF detection algorithm

The PPG-based atrial fibrillation detection algorithm is a non-invasive signal processing approach that analyzes photoplethysmographic waveforms obtained during remote monitoring. The algorithm evaluates pulse-to-pulse variability, waveform characteristics, and signal quality parameters to identify irregular rhythm patterns associated with atrial fibrillation and provide early detection of potential arrhythmic events.

Locations (1)

Premedix

Bratislava, Slovakia