Use of AliveCor ECG Monitoring to Replicate ECG Lead Recording

• Sponsor: Mayo Clinic (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04472520
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The researchers are trying to determine whether the Alivecor device can simulate other electrocardiogram (ECG) leads to record electrical activity.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmia	Device: AliveCor Heart Monitor	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Use of AliveCor ECG Monitoring to Replicate ECG Lead Recording
• Anticipated Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Electrocardiogram (ECG) QT Interval [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Individuals greater than 18 years old getting an ECG

Exclusion Criteria:

• Patients unwilling or unable to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Arizona	Phoenix	Arizona	United States	85054

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Dan Sorajja, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Dan Sorajja, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04472520
• Other Study ID Numbers: 18-002678
• First Posted: Jul 15, 2020
• Last Update Posted: Jul 15, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Arrhythmias, Cardiac

Study Results

No Results Posted as of Jul 15, 2020