Use of AliveCor ECG Monitoring to Replicate ECG Lead Recording
Primary Purpose
Arrhythmia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AliveCor Heart Monitor
Sponsored by
About this trial
This is an interventional diagnostic trial for Arrhythmia
Eligibility Criteria
Inclusion Criteria:
- Individuals greater than 18 years old getting an ECG
Exclusion Criteria:
- Patients unwilling or unable to provide informed consent
Sites / Locations
- Mayo Clinic Arizona
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subject getting an ECG
Arm Description
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.
Outcomes
Primary Outcome Measures
Electrocardiogram (ECG) QT Interval
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04472520
Brief Title
Use of AliveCor ECG Monitoring to Replicate ECG Lead Recording
Official Title
Use of AliveCor ECG Monitoring to Replicate ECG Lead Recording
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
lack of enrollment
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The researchers are trying to determine whether the Alivecor device can simulate other electrocardiogram (ECG) leads to record electrical activity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subject getting an ECG
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
AliveCor Heart Monitor
Intervention Description
Records single-channel ECG rhythms
Primary Outcome Measure Information:
Title
Electrocardiogram (ECG) QT Interval
Description
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
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Individuals greater than 18 years old getting an ECG
Exclusion Criteria:
Patients unwilling or unable to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Sorajja, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Use of AliveCor ECG Monitoring to Replicate ECG Lead Recording
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