Confirmatory Clinical Investigation of Electrocardiographic Diagnostic Performance of the Apple Watch Augmented With an Artificial Intelligence Algorithm
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Cardiologs Technologies
- Enrollment
- 220
- Locations
- 3
- Primary Endpoint
- Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF (Atrial Fibrillation or Flutter) as identified by the physician on the 12-lead ECG
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF (Atrial Fibrillation or Flutter) as identified by the physician on the 12-lead ECG
Time Frame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF (Atrial Fibrillation or Flutter) as identified by the physician on the 12-lead ECG in the independent annotation center, providing the ground truth from the 12-lead ECG
Secondary Outcomes
- Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF as identified by the physician on the smartwatch ECG(Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital)
- Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Sinus Rhythm as identified by the physician on the smartwatch ECG(Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital)
- Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Premature Supraventricular Complexes as identified by the physician on the smartwatch ECG(Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital)
- Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Premature Ventricular Complexes as identified by the physician on the smartwatch ECG(Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital)
- Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Tachycardia as identified by the physician on the smartwatch ECG(Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital)
- Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Bradycardia as identified by the physician on the smartwatch ECG(Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital)
- Assessment of the proportion of smartwatch ECGs identified as inconclusive by Cardiologs Artificial Intelligence and by the physician(Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital)