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NCT07749183
A Photoplethysmography-Based Machine Learning Algorithm for Early Atrial Fibrillation Detection: A Prospective Validation Study
Conditions: Atrial Fibrillation (AF), Heart Failure
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 200
Sponsor: Seerlinq s. r. o.
Location: Premedix Bratislava
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07749183). StuddyBuddy aggregates publicly available trial information.