Avidhrt Clinical Equivalence Study

Avidhrt Clinical Equivalence of ECG

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05357209

Enrollment

Registered

2022-05-02

Start date

2022-05-15

Completion date

2022-07-30

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

ECG Equivalence

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.

Interventions

DEVICEAvidhrt Sense Heart Monitor

Use of Avidhrt Sense Heart Monitor review ECG signals.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Avidhrt Sense ECG equivalency	12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026