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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Bradycardia; Tachycardia; Premature Ventricular Contraction; Premature Supraventricular Beat
• Intervention / Treatment: Device: Cardiologs Platform

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.

• Study Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack Meridian School of Medicine
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center/ NewYork Presbyterian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

200 subjects: subjects who are hospitalized for cardioversion or AF ablation procedure per standard of care

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Cardiologs Technologies
• Investigators: Principal Investigator: Elaine Y Wan, MD, Columbia University, New York

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2022
• Primary Completion (Actual): January 20, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Cardiac Complexes, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Atrial Fibrillation; Premature Birth; Bradycardia; Tachycardia; Ventricular Premature Complexes; Atrial Premature Complexes
• Other Study ID Numbers: SWAF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No