Performance and Accuracy of an AI Enhanced Smart Watch Single Lead ECG

NCT ID: NCT05450809

Last Updated: 2022-12-28

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

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-05

Study Completion Date

2022-11-02

Brief Summary

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The purpose of this study is to show the artificial intelligence enhanced single-lead ECG Apple Watch has similar, robust performance comparable to an AI enhanced 12 lead ECG and AI enhanced single lead (LI) of a 12 lead ECG.

Detailed Description

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1. Ambulatory patients undergoing ECG recording in the Mayo Clinic outpatient ECG lab will be asked to consent for this study.
2. Those who consent for the study will be asked to record a ECG using a single-lead watch-based (Apple Watch series 5) recording at a visit for a clinically scheduled 12 lead ECG recording.
3. This watch-based ECG data will be recorded and analyzed in comparison to the near-simultaneously recorded outpatient 12 Lead ECG

Conditions

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Healthy

Keywords

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electrocardiogram wearable artificial intellegence Apple Watch

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ambulatory, outpatient Mayo Clinic ECG lab patients

Patients who are undergoing routine clinical evaluation with a 12 lead ECG recording ordered at the Mayo Clinic ECG lab.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years and ≤ 89.
* Able to give verbal consent.
* Able to complete routine clinical 12 lead ECG tracing and single lead Apple Watch ECG tracing.

Exclusion Criteria

* Individuals \< 18 and \> 89 years of age.
* Unable to given verbal consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Itzhak Zachi Attia

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Itzhak Zachi Attia, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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21-006770

Identifier Type: -

Identifier Source: org_study_id