Detection of Atrial Fibrillation Using PPG From Smartphone Cameras
Recruiting · NCT07779213 · Observational (researchers observe without assigning treatment) · Lead sponsor: Happitech BV
View the official record on ClinicalTrials.gov →Interventions studied
12 Lead ECG is compared to a smartphone based PPG
What this trial is about
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.
Who can take part
Age range
22 Minutes and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Adults aged 22 years or older
- Owns a smartphone and knows how to operate and navigate different applications.
- Individuals able to read, understand, and sign the consent form.
- Cardiology patients consulting the cardiac outpatient clinic.
- History of persistent AF or other cardiac rhythm
Exclusion criteria
- Participants with cognitive impairments
- Individuals who cannot read, speak, and/or understand English
- 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
Where it is running
5 locations listed across 4 US states.
- Nair Research, LLC dba Arrhythmia Research Group LLC - Jonesboro, Arkansas, United States
- South Denver Cardiology - Littleton, Colorado, United States
- Tulane University - New Orleans, Louisiana, United States
- CardioVascular Health Clinic - Oklahoma City, Oklahoma, United States
- Isala Zwolle - Zwolle, Overijssel, Netherlands