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

Cardiologs Technologies

Status: Completed

Conditions: Bradycardia; Atrial Fibrillation; Tachycardia; Premature Ventricular Contraction; Premature Supraventricular Beat

Treatments: Device: Cardiologs Platform

Study type: Observational

Funder types: Industry

Identifiers

NCT05167058

SWAF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Subjects with paced rhythm or implanted electronic devices
• Pregnant or breast-feeding subjects