Avidhrt Clinical Equivalence Study

NCT05357209 | Unknown FDA Device

• 1 other identifier: ACES-01
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

ECG Equivalence

Outcome Measures

Primary Outcomes (1)

• Avidhrt Sense ECG equivalency

  12 months

Study Arms (2)

Arm A

OTHER

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

Arm B

OTHER

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

Interventions

Avidhrt Sense Heart Monitor DEVICE

Use of Avidhrt Sense Heart Monitor review ECG signals.

Arm A; Arm B

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Avidhrt Inc.: lead
• ASCENSION SACRED HEART: collaborator
• Michigan State University: collaborator
• Spring Arbor University: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 2, 2022
• Study Start: May 15, 2022
• Primary Completion: July 15, 2022
• Study Completion: July 30, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04