Avidhrt Clinical Equivalence Study | NCT05357209

Studies
Avidhrt Clinical Equivalence Study

NCT05357209

Sponsor

Avidhrt Inc.

Status

Unknown status

Last Update Posted

May 2, 2022Actual

Enrollment

75Estimated

Phase

Not Applicable

Conditions

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

Interventions

Avidhrt Sense Heart Monitor

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2022Estimated

Primary Completion Date

Jul 15, 2022Estimated

Completion Date

Jul 30, 2022Estimated

First Submitted Date

Apr 27, 2022

First Submission Date that Met QC Criteria

Apr 27, 2022

First Posted Date

May 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2022

Last Update Posted Date

May 2, 2022Actual

Name	Class
ASCENSION SACRED HEART	UNKNOWN
Michigan State University	OTHER
Spring Arbor University	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Avidhrt Sense Heart Monitor	Device	Use of Avidhrt Sense Heart Monitor review ECG signals.	Arm A Arm B

Measure	Description	Time Frame
Avidhrt Sense ECG equivalency		12 months

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided