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Avidhrt Clinical Equivalence Study

NCT05357209 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-05-02

No results posted yet for this study

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

Interventions

DEVICE

Avidhrt Sense Heart Monitor

Use of Avidhrt Sense Heart Monitor review ECG signals.

Sponsors & Collaborators

  • ASCENSION SACRED HEART

    collaborator UNKNOWN

  • Michigan State University

    collaborator OTHER

  • Spring Arbor University

    collaborator UNKNOWN

  • Avidhrt Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-15
Primary Completion
2022-07-15
Completion
2022-07-30
FDA Device
Yes

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05357209 on ClinicalTrials.gov