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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05167058
• Other study ID #: SWAF
• Status: Completed
• Start date: April 21, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: October 2023
• Source: Cardiologs Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 31, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Premature Complexes
• Bradycardia
• Premature Birth
• Premature Ventricular Contraction
• Tachycardia
• Ventricular Premature Complexes

Intervention

Device:
• Cardiologs Platform
Smartwatch recordings interpreted by Cardiologs AI done simultaneously with each 12-lead ECG

Locations

Country	Name	City	State
United States	Hackensack Meridian School of Medicine	Hackensack	New Jersey
United States	Columbia University Medical Center/ NewYork Presbyterian Hospital	New York	New York
United States	The Valley Hospital	Ridgewood	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Cardiologs Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Secondary	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.	Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Secondary	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.	Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Secondary	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.	Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Secondary	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.	Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Secondary	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.	Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Secondary	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.	Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Secondary	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.	Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital