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)
Facility
City
Region
Status
Nair Research, LLC dba Arrhythmia Research Group LLC
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.
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