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Clinical Trials in the Netherlands / NCT07779213
Recruiting Observational

Detection of Atrial Fibrillation Using PPG From Smartphone Cameras

NCT07779213 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Happitech BV
Phase
Observational
Started
2026-06-30
Last updated
2026-08-21

Condition(s) studied

Atrial Fibrillation (AF)

Investigational drug(s) / intervention(s)

12 Lead ECG is compared to a smartphone based PPG

12 Lead ECG is compared to a smartphone based PPG: 12 Lead ECG is compared to a smartphone based PPG

Study summary

The protocol is designed to enroll patients from at least 3 diverse clinical sites with smartphones who are being evaluated for the presence or absence of atrial fibrillation (AF) using the Heart Rhythm Software algorithm running on their smartphones. Algorithm output will be compared to a gold standard of 12-lead ECG recorded with a simultaneous PPG measurement.

Eligibility

Sex
ALL
Min age
22 Minutes
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Adults aged 22 years or older 2. Owns a smartphone and knows how to operate and navigate different applications. 3. Individuals able to read, understand, and sign the consent form. 4. Cardiology patients consulting the cardiac outpatient clinic. 5. History of persistent AF or other cardiac rhythm Exclusion Criteria: 1. Participants with cognitive impairments 2. Individuals who cannot read, speak, and/or understand English 3. Patients with implantable neurostimulators, cardiac implantable device in an atrial or ventricular paced rhythm documented on a 12-lead ECG during the initial study visit

Primary outcome measure(s)

  • To evaluate the sensitivity and specificity of the Heart Rhythm Software — Through study completion, an average of 6 months
    To evaluate the sensitivity and specificity of the Heart Rhythm Software algorithm running on a commercially available smartphone to detect atrial fibrillation segments using photoplethysmography (PPG) as measured through the phone's camera. Se is defined as the percentage of patients with 90 second interval recordings scored by the Heart Rhythm Software algorithm as AF, out of all intervals determined by the Clinical Adjudication Committee (CAC) to be AF (gold standard). Sp is defined as the percentage of patients with 90 second intervals scored by the Heart Rhythm Software algorithm as NSR out of all ECG recordings determined by the CAC to be NSR.

Trial sites (5)

FacilityCityRegionStatus
Nair Research, LLC dba Arrhythmia Research Group LLC Jonesboro Arkansas Recruiting
South Denver Cardiology Littleton Colorado Recruiting
Tulane University New Orleans Louisiana Not Yet Recruiting
CardioVascular Health Clinic Oklahoma City Oklahoma Recruiting
Isala Zwolle Zwolle Overijssel Recruiting

Other trials for the same condition

Diagnostic Electrical Cardioversion for Explaining Patient's AF and HF Symptoms Starting soon
High Power Short Duration Radiofrequency Ablation of Atrial Fibrillation Using the QDOT MICRO™ Catheter Active, not recruiting
AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation Starting soon
Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation Recruiting
Clinical Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07779213 on ClinicalTrials.gov ↗ ← All trials in the Netherlands