Heart Failure Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Slovakia
Premedix
RECRUITING
Bratislava
Contact Information
Primary
Marta Kollárová, MSc., PhD.
marta.kollarova@premedix.org
+421 950 896 026
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2026-11
Participants
Target number of participants: 200
Treatments
Documented AF
HF patients with a history of permanent/paroxysmal AF and AF documented on 12-lead ECG at enrollment
Non-AF
HF patients in sinus rhythm on the index 12-lead ECG with no prior documented AF episodes
Related Therapeutic Areas
Sponsors
Collaborators: Premedix Academy, ACADEMY - občianske združenie
Leads: Seerlinq s. r. o.

This content was sourced from clinicaltrials.gov