Avidhrt Clinical Equivalence Study

NCT ID: NCT05357209

Last Updated: 2022-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-15
• Study Completion Date: 2022-07-30

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.

Conditions

Equivalence of ECG Electrode Type Signal Quality for AF and Non AF Users

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Avidhrt Sense Heart Monitor

Intervention Type: DEVICE

Use of Avidhrt Sense Heart Monitor review ECG signals.

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.

Group Type: OTHER

Avidhrt Sense Heart Monitor

Intervention Type: DEVICE

Use of Avidhrt Sense Heart Monitor review ECG signals.

Interventions

Avidhrt Sense Heart Monitor

Use of Avidhrt Sense Heart Monitor review ECG signals.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ASCENSION SACRED HEART

UNKNOWN

Sponsor Role: collaborator

Michigan State University

OTHER

Sponsor Role: collaborator

Spring Arbor University

UNKNOWN

Sponsor Role: collaborator

Avidhrt Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ACES-01

Identifier Type: -

Identifier Source: org_study_id