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

NCT ID: NCT05167058

Last Updated: 2023-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-21

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation Tachycardia Bradycardia Premature Supraventricular Beat Premature Ventricular Contraction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Cardiologs Platform

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

Intervention Type DEVICE

Other Intervention Names

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Smartwatch

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiologs Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elaine Y Wan, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University, New York

Locations

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Hackensack Meridian School of Medicine

Hackensack, New Jersey, United States

Site Status

The Valley Hospital

Ridgewood, New Jersey, United States

Site Status

Columbia University Medical Center/ NewYork Presbyterian Hospital

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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SWAF

Identifier Type: -

Identifier Source: org_study_id

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