NCT05167058

Electrocardiographic Diagnostic Performance of the Apple Watch Augmented With an Artificial Intelligence Algorithm

Confirmatory Clinical Investigation of Electrocardiographic Diagnostic Performance of the Apple Watch Augmented With an Artificial Intelligence Algorithm

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 220 (actual)
• Sponsor: Cardiologs Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The SWAF study is a prospective, non-significant risk, non-randomized, multicentric, open, comparative, confirmatory study. Under subject consent, subjects hospitalized for cardioversion or AF ablation will have a smartwatch ECG recording done simultaneously with 12-lead ECG measurement right before the intervention. If a subject is found in Normal Sinus Rhythm he/she will be discharged otherwise the patient will undergo cardioversion and will have simultaneous recordings done a second time after the intervention. All the measurements will be done in accordance with the existing subject monitoring protocol.

Conditions

• Atrial Fibrillation
• Tachycardia
• Bradycardia
• Premature Supraventricular Beat
• Premature Ventricular Contraction

Interventions

Type	Name	Description
DEVICE	Cardiologs Platform	Smartwatch recordings interpreted by Cardiologs AI done simultaneously with each 12-lead ECG

Timeline

• Start date: 2022-04-21
• Primary completion: 2023-01-20
• Completion: 2023-03-31
• First posted: 2021-12-22
• Last updated: 2023-10-03

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study