Avidhrt Clinical Equivalence Study

Avidhrt Clinical Equivalence of ECG

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Equivalence of ECG Electrode Type Signal Quality for AF and Non AF Users
• Intervention / Treatment: Device: Avidhrt Sense Heart Monitor

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm A; Arm A of the Avidhrt study will contain subjects that have been/are diagnosed with AF. Arm A of the study will have the participants complete the Human Factors sub-study in addition to the primary clinical study.	Device: Avidhrt Sense Heart Monitor; Use of Avidhrt Sense Heart Monitor review ECG signals.
Other: Arm B; Arm B of the Avidhrt study will contain all other subjects (those non diagnosed with AF), and participants will receive the option whether to participate in the Human Factors sub-study.	Device: Avidhrt Sense Heart Monitor; Use of Avidhrt Sense Heart Monitor review ECG signals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Avidhrt Sense ECG equivalency	12 months

Collaborators and Investigators

• Sponsor: Avidhrt Inc.
• Collaborators: Michigan State University; ASCENSION SACRED HEART; Spring Arbor University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2022
• Primary Completion (Anticipated): July 15, 2022
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: ECG Equivalence
• Other Study ID Numbers: ACES-01

Drug and device information, study documents

• 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