Status:
UNKNOWN
Avidhrt Clinical Equivalence Study
Lead Sponsor:
Avidhrt Inc.
Collaborating Sponsors:
ASCENSION SACRED HEART
Michigan State University
Conditions:
Equivalence of ECG Electrode Type Signal Quality for AF and Non AF Users
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The Avidhrt Clinical Equivalence Study will test and evaluate the equivalency between ECG signals acquired simultaneously using the Avidhrt Sense Lead-1 ECG, and an FDA cleared Lead-12 gel ECG. The Av...
Detailed Description
This study will test the clinical equivalency of an Avidhrt Sense acquired Lead-I ECG signal and a Lead-I ECG signal obtained from an FDA cleared 12-lead-ECG gel electrode.The Avidhrt Clinical Equival...
Eligibility Criteria
Inclusion
- Adults ≥ 22 years old at the time of enrollment
- Capable of giving informed consent
- Sufficient manual dexterity to capture an ECG using Avidhrt Sense
- Subjects in the arrhythmia group must have a known history of arrhythmia, and may have an arrhythmia at the time of enrollment based on the screening ECG just before the study recordings are taken.
Exclusion
- Cardiac pacemaker or implantable cardioverter-defibrillator
- History of a life-threatening rhythm such as ventricular tachycardia or ventricular fibrillation
- Anti-arrhythmic (rhythm control) medication use (such as amiodarone or flecainide)
- Subjects in the normal controls group should not have any history of arrhythmia and should not be in arrhythmia at the time of enrollment based on the screening ECG
- Subjects with tremors who are unable to stably hold the Avidhrt Sense during a recording without movement
Key Trial Info
Start Date :
May 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2022
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05357209
Start Date
May 15 2022
End Date
July 30 2022
Last Update
May 2 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.