The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05617001
Recruitment Status : **RECRUITING NOW**
First Posted : November 15, 2022
Last Update Posted : November 15, 2022
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
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Brief Summary:
AliveCor (www.alivecor.com) has developed an ECG device (KardiaMobile) that interfaces with iOS and Android smartphones and tablets. This ECG consists of a lightweight hardware case with two metal electrodes that can snap onto the back of the phone and a software application. By holding the right finger(s) on the right electrode and the left finger(s) on the left electrode, an electrical circuit is completed and a lead-I, 30 second rhythm strip is created. KardiaMobile and a newer device, KardiaMobile 6L, were approved by FDA for ECG rhythm recording. Recently, AliveCor developed a new device: Kardia 12L to record 12-lead ECGs. However, the data generated from the new device has not yet been validated for accuracy. The specific aim of this study is to evaluate the accuracy and safety of the AC 12L ECG System. The ECGs collected by the AC 12L ECG System will be compared to simultaneous standard- of-care 12-lead ECG, recorded using the GE CardioSoft 12-lead ECG System. The ECGs will be analyzed for accuracy based on statistical difference using root-mean-square error, and cross correlation between the simultaneous 10 second recordings as well as the median beats of all 12 leads.
Arrhythmia
Device: Kardia 12L
Not Applicable
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Study Type :
Interventional  (Clinical Trial)
Estimated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Clinical Validation and Safety of the AC 12L ECG System Against a Standard of Care 12-Lead ECG (AC 12L ECG)
Actual Study Start Date :
October 4, 2022
Estimated Primary Completion Date :
January 31, 2023
Estimated Study Completion Date :
March 31, 2023
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Intervention Details:
Device: Kardia 12L
The purpose of this study is to collect clinical validation data to support an FDA submission for a 510(k) for the Kardia 12L hardware which enables the simultaneous diagnostic quality recording of all 6 limb leads and any chest lead. We will be recording both Leads V1 and V2 in a sequential fashion along with the V4 and Limb leads and a simultaneous 12-lead ECG to validate the hardware and a Deep Neural Network model which expands the 5 leads into a complete 12-lead ECG. The 12-lead ECG used for validation of the recordings and the 12-lead synthesis model is the GE Cardiosoft System which is FDA cleared.
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Primary Outcome Measures :
Agreement on QRS width between Kardia 12L and ECG [ Time Frame: 30 seconds ]
Quantitative analysis on QRS width will be performed on the median-beat ECGs derived from the recorded ECGs from the device as well as 12-lead ECG for each study participant
Agreement on PR interval between Kardia 12L and ECG [ Time Frame: 30 seconds ]
Quantitative analysis on PR interval will be performed on the median-beat ECGs derived from the recorded ECGs from the device as well as 12-lead ECG for each study participant
Agreement on AT interval between Kardia 12L and ECG [ Time Frame: 30 seconds ]
Quantitative analysis on AT interval will be performed on the median-beat ECGs derived from the recorded ECGs from the device as well as 12-lead ECG for each study participant
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Information from the National Library of Medicine
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Ages Eligible for Study: Â
18 Years and older  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Accepts Healthy Volunteers: Â
Yes
Inclusion Criteria:
Male or female patients 18 years or older
Ability to remain supine for a conventional 12 lead AliveCor 12L ECG recording for approximately 15 minutes
Exclusion Criteria:
Open chest wounds or recent (<30 days) surgery to the chest or abdomen
Absence of any limb that would require modification of the lead set-up
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05617001
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Contact: Michael Stout, RN   405-271-9060 ext 44761   michael-h-stout@ouhsc.edu  Â
University of Oklahoma
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Principal Investigator:
Stavros Stavrakis, MD, PhD
University of Oklahoma
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Responsible Party:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT05617001 Â Â
Other Study ID Numbers:
PRO-0012
First Posted:
November 15, 2022 Â Â Key Record Dates
Last Update Posted:
November 15, 2022
Last Verified:
November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Undecided
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Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
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Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic Processes
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
