A Photoplethysmography-Based Machine Learning Algorithm for Early Atrial Fibrillation Detection: A Prospective Validation Study
Recruiting · NCT07749183 · Observational (researchers observe without assigning treatment) · Lead sponsor: Seerlinq s. r. o.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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)
Exclusion criteria
- Missing a valid PPG recording
Where it is running
2 locations listed.
- Premedix - Bratislava, Slovakia
- Premedix - Bratislava, Slovakia