Avidhrt Clinical Equivalence Study

Avidhrt

Status: Unknown

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

Treatments: Device: Avidhrt Sense Heart Monitor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05357209

ACES-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Arm A

Other group

Description:

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.

Treatment:

Device: Avidhrt Sense Heart Monitor

Arm B

Other group

Description:

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.

Treatment:

Device: Avidhrt Sense Heart Monitor