Ignite Creation Date:
2024-05-06 @ 6:18 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05617001
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2022-11-07
Brief Title:
Clinical Validation and Safety of the AC 12L ECG System Against a Standard of Care 12-Lead ECG AC 12L ECG
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
Clinical Validation and Safety of the AC 12L ECG System Against a Standard of Care 12-Lead ECG AC 12L ECG
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
AliveCor wwwalivecorcom 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 fingers on the right electrode and the left fingers 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None