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.
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.
Study Type
OBSERVATIONAL
Enrollment
220
Smartwatch recordings interpreted by Cardiologs AI done simultaneously with each 12-lead ECG
Hackensack Meridian School of Medicine
Hackensack, New Jersey, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Columbia University Medical Center/ NewYork Presbyterian Hospital
New York, New York, United States
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
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
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 as identified by the physician on the smartwatch ECG
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF as identified by the physician on the smartwatch ECG in the independent annotation center, providing the ground truth from the smartwatch 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 Sinus Rhythm as identified by the physician on the smartwatch ECG
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 in the independent annotation center, providing the ground truth from the smartwatch 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 Tachycardia as identified by the physician on the smartwatch ECG
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Tachycardia as identified by the physician on the smartwatch ECG in the independent annotation center, providing the ground truth from the smartwatch ECG.
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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 Bradycardia as identified by the physician on the smartwatch ECG
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Bradycardia as identified by the physician on the smartwatch ECG in the independent annotation center, providing the ground truth from the smartwatch 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 Premature Supraventricular Complexes as identified by the physician on the smartwatch ECG
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 in the independent annotation center, providing the ground truth from the smartwatch 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 Premature Ventricular Complexes as identified by the physician on the smartwatch ECG
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 in the independent annotation center, providing the ground truth from the smartwatch ECG.
Time frame: 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
Assessment of the proportion of smartwatch ECGs identified as inconclusive by Cardiologs Artificial Intelligence and by the physician. Inconclusive may mean that there may have been too much artefact or noise to acquire a good signal or that the rhythm is unclassifiable or contains other abnormal rhythm.
Time frame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital