The purpose of the study is to confirm the Garmin ECG (electrocardiogram) software algorithm can detect and classify atrial fibrillation and normal sinus rhythm on single lead ECG data derived from a Garmin wrist-worn, consumer device. The study will also confirm the software's ability to create a Lead I ECG that is clinically equivalent to a reference device. The Garmin ECG software is not a diagnostic system and is intended for informational purposes only.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
568
Simultaneous assessment of the heart rhythm determined from a 12-lead ECG and the Garmin ECG software algorithm heart rhythm classification on single-lead ECG data derived from the wearable device. All participants will record three simultaneous 12-lead and single-lead ECGs.
Hope Research Institute
Phoenix, Arizona, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
HealthEast
Saint Paul, Minnesota, United States
Northwell Health North Shore University Hospital
Manhasset, New York, United States
Specificity of rhythm classification
Number of participants with a SR software rhythm classification in agreement with a physician's interpretation of heart rhythm based on gold standard 12-lead ECG
Time frame: 1 Day
Sensitivity of rhythm classification
Number of participants with an AF software rhythm classification in agreement with a physician's interpretation of heart rhythm based on gold standard 12-lead ECG
Time frame: 1 Day
Number of ECGs that pass a visual overlay
Number of participants with software's ability to produce a clinically equivalent waveform in agreement to a gold standard Lead I reference
Time frame: Day 1
Difference in R-wave amplitudes between the software and gold standard reference
Number of participants with software's ability to produce a clinically equivalent waveform in agreement to a gold standard Lead I reference
Time frame: Day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Northwell Health Lenox Hill Hospital
New York, New York, United States
MedStar Health Cardiac Electrophysiology at Fairfax
Fairfax, Virginia, United States