Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy

Keywords

electrocardiogramwearableartificial intellegenceApple Watch

Outcome Measures

Primary Outcomes (2)

Comparison of 12 lead ECG features to single-lead watch-based ECG features
The ECG interval differences (in milliseconds) between 12 Lead and collected single-lead watch-based ECG for PR, QRS, QT intervals will be determined and compared for each patient.
12 months
Arrhythmia comparison of 12 lead ECG to single-lead watch-based ECG
A physician interpretation of patients' 12 lead ECG and single-lead watch-based ECG will be performed to determined underlying rhythm (i.e. sinus rhythm, atrial fibrillation etc) from each, and the results from these modalities will be compared.
12 months

Secondary Outcomes (1)

Arrhythmia classification by physician overread of single-lead watch-based ECG
12 months

Other Outcomes (5)

Artificial intelligence detection of heart failure by single-lead watch-based ECG
12 months
Artificial intelligence detection of silent/paroxysmal atrial fibrillation by single-lead watch-based ECG
12 months
Artificial intelligence detection of aortic stenosis by single-lead watch-based ECG
12 months
+2 more other outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 89 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Ambulatory patients who are undergoing a clinically ordered electrocardiogram in the Mayo Clinic outpatient ECG lab.

You may qualify if:

Age ≥ 18 years and ≤ 89.

Sponsors & Collaborators

Mayo Clinic
Otherlead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Study Officials

Itzhak Zachi Attia, PhD
Mayo Clinic
PRINCIPAL INVESTIGATOR

Enrollment

1,000 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

July 5, 2022

First Posted

July 11, 2022

Study Start

November 5, 2021

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Other Outcomes (5)

Study Arms (1)

Ambulatory, outpatient Mayo Clinic ECG lab patients

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Other Outcomes (5)

Study Arms (1)

Ambulatory, outpatient Mayo Clinic ECG lab patients

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations