Confirmatory Clinical Investigation of Electrocardiographic Diagnostic Performance of the Apple Watch Augmented With an Artificial Intelligence Algorithm
Status: Completed
Location: See all (3) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
The SWAF study will compare the performance of a smartwatch combined with Cardiologs Platform algorithm in the detection of Atrial Fibrillation and other arrhythmias with that measured on a manually read 12-lead ECG in subjects hospitalized for cardioversion or AF ablation.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subjects over 18, able and willing to participate in the study
• Subjects who are admitted to the hospital for a cardioversion or AF ablation procedure.
• Subjects having read the patient information letter and provided his/her consent to participate in writing, by dating and signing the informed consent prior to any trial-related procedure being conducted
Locations
United States
New Jersey
Hackensack Meridian School of Medicine
Hackensack
The Valley Hospital
Ridgewood
New York
Columbia University Medical Center/ NewYork Presbyterian Hospital
New York
Time Frame
Start Date: 2022-04-21
Completion Date: 2023-03-31
Participants
Target number of participants: 220
Authors
Elain Y Wan, Taya V Glotzer
Related Therapeutic Areas
Sponsors
Leads: Cardiologs Technologies