Electrocardiographic Diagnostic Performance of the Apple Watch Augmented With an Artificial Intelligence Algorithm
NCT ID: NCT05167058
Last Updated: 2023-10-03
Study Results
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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COMPLETED
220 participants
OBSERVATIONAL
2022-04-21
2023-03-31
Brief Summary
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Detailed Description
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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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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Cardiologs Platform
Smartwatch recordings interpreted by Cardiologs AI done simultaneously with each 12-lead ECG
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant or breast-feeding subjects
18 Years
ALL
No
Sponsors
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Cardiologs Technologies
INDUSTRY
Responsible Party
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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
The Valley Hospital
Ridgewood, New Jersey, United States
Columbia University Medical Center/ NewYork Presbyterian Hospital
New York, New York, United States
Countries
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Other Identifiers
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SWAF
Identifier Type: -
Identifier Source: org_study_id
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