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

NCT05167058 | Completed FDA Device

• 1 other identifier: SWAF
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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 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

• 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

Interventions

Cardiologs Platform DEVICE

Smartwatch recordings interpreted by Cardiologs AI done simultaneously with each 12-lead ECG

Also known as: Smartwatch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cardiologs Technologies: lead

Study Sites (3)

Hackensack Meridian School of Medicine

Hackensack, New Jersey, 07601, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Columbia University Medical Center/ NewYork Presbyterian Hospital

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia; Bradycardia; Atrial Premature Complexes; Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease; Cardiac Complexes, Premature

Study Officials

• Elaine Y Wan, MD

  Columbia University, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 22, 2021
• Study Start: April 21, 2022
• Primary Completion: January 20, 2023
• Study Completion: March 31, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)