Clinical Performance of the AFGen1 Device Over a 7-day Period

NCT ID: NCT05295056

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-12

Study Completion Date

2023-08-25

Brief Summary

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AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib. The purpose of this study is to establish the clinical performance of the AFib-Chek device (a.k.a. Device) on human participants.

Detailed Description

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The primary purpose of this study is to demonstrate that the ECD signal acquired by the AFGen1 device is as of adequate quality and is suitable to support its intended use for the detection of AFib.

Conditions

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Atrial Fibrillation Afib Irregular Heart Beat Arrhythmias, Cardiac Arrhythmia Atrial Arrhythmias Paroxysmal Paroxysmal Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Permanent atrial fibrillation

Known to have permanent atrial fibrillation

AFGen1 Device Wear Test

Intervention Type DEVICE

Participant wears the device for 7 days

Healthy control

Healthy controls

AFGen1 Device Wear Test

Intervention Type DEVICE

Participant wears the device for 7 days

AFGen 1 Device Single Use

Intervention Type DEVICE

Participant wears the device in conjunction with a standard ECG

Interventions

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AFGen1 Device Wear Test

Participant wears the device for 7 days

Intervention Type DEVICE

AFGen 1 Device Single Use

Participant wears the device in conjunction with a standard ECG

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1\. 18+ willing to sign the consent form

Exclusion Criteria

1. Implanted pacemakers
2. Implanted cardioverter defibrillators
3. Implanted cardiac resynchronization devices
4. Potential life-threatening arrythmias
5. Physical or mental health conditions that would prevent the person from being able to follow instruc-tions regarding participation in the study
6. Open wounds, abraded or irritated skin at the application site
7. Planned to undergo a MRI during the course of the study duration
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TriVirum, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clayton Sleep Institute

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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AFib-Chek-001

Identifier Type: -

Identifier Source: org_study_id

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