Use of AliveCor ECG Monitoring to Replicate ECG Lead Recording

July 10, 2020 updated by: Dan Sorajja, Mayo Clinic
The researchers are trying to determine whether the Alivecor device can simulate other electrocardiogram (ECG) leads to record electrical activity.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals greater than 18 years old getting an ECG

Exclusion Criteria:

  • Patients unwilling or unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subject getting an ECG
Subjects getting an ECG will have AliveCore tracings obtained in 3 configurations; between right hand and left hand, between left hand and left lower leg (thigh, calf, and foot) and between right hand and left lower leg (thigh, calf, and foot).These configurations will be obtained with the participant lying in bed and in a sitting position.
Device: AliveCor Heart Monitor
Records single-channel ECG rhythms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrocardiogram (ECG) QT Interval
Time Frame: 1 day
The QT interval represents the time of ventricular activity including both depolarization and repolarization. It is measured from the beginning of the QRS complex to the end of the T wave. Normally, the QT interval is 0.36 to 0.44 seconds
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Dan Sorajja, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

June 5, 2020

First Submitted That Met QC Criteria

July 10, 2020

First Posted (Actual)

July 15, 2020

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-002678

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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