Clinical trial NCT05357209: Avidhrt Clinical Equivalence Study
Official title: Avidhrt Clinical Equivalence of ECG
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Equivalence of ECG Electrode Type Signal Quality for AF and Non AF Users
Keywords: ECG Equivalence
Lead sponsor: Avidhrt Inc.
Sponsor class: INDUSTRY
Collaborators: name: ASCENSION SACRED HEART
name: Michigan State University
name: Spring Arbor University
First posted: 2022-05-02
Enrollment: 75
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is divided into two arms. Arm A will contain subjects with diagnosed AF, and arm B will contain all other subjects. This is a prospective, parallel-cohort, non-randomized study using an enriched population.
Primary purpose: BASIC_SCIENCE

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 Avidhrt Clinical Equivalence Study also includes a sub-study. The Avidhrt Sense Human Factors sub-study will evaluate the usability and efficacy of the user-interface of the Avidhrt Sense device.

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 Equivalence study is comprised of study Arm A and Arm B. In Arm A of this study the population is comprised exclusively of subjects with AF, who will be asked to participate in the Clinical Equivalence Study and in the Human Factors Sub-Study. In Arm B of this study the population will consist of all other subjects (no AF), who will be asked to participate in the Clinical Equivalence Study, with the option to enroll and participate in the Human Factors Sub-Study. This is a prospective, parallel-cohort, non-randomized study using an enriched population.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Avidhrt Sense ECG equivalency
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: