Further Study of AFGen1 Clinical Performance

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

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-02

Study Completion Date

2024-04-19

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 further evidence for the clinical performance of AFGen1 on human participants.

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Detailed Description

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The primary purpose of this study is to demonstrate the ECG signal acquired by the AFGen1 device is of adequate quality and is suitable to support its intended use for the detection of Afib. This will be evaluated by comparing the ECG data acquired by AFGen1 to that acquired by an FDA cleared 12-lead ECG device using a Bland-Altman analysis of the R-R intervals and R amplitude measurements and Eigenvector magnitudes derived from principal component analyses of simultaneously captured waveforms measured by both devices by both devices. The ECG waveforms from both devices will also be adjudicated by 2 independent cardiologists. The study will also seek to demonstrate that there is no degradation in the quality of the ECG signal it acquires when the device is placed in an anticipated misplacement position to that directed by the instructions for use of the device. Finally the study will seek to confirm the adhesive performance of the device is appropriate to support its intended use per the requirements of sections 4.4 and 5.4 of ANSI AAMI EC12-1 . Another purpose of the study is to collect extended 5 minute ECG recordings by the subject periodically triggering the device while wearing the device for 7 (+3) days. This data will be used for product development purposes.

Conditions

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Atrial Fibrillation Afib ECG

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Wear AFGen1 for at least 7 days

Wear AFGen1 for 7 to 10 days. ECG co-measurement with 12 lead device at start and periodic measurements of ECG with AFGen1 during wear period

ECG co-measurement

Intervention Type DEVICE

Measure ECG with 12 lead device at same time that AFGen1 is monitoring ECG

Periodic ECG triggered measurement

Intervention Type DEVICE

Subject triggers AFGen1 to perform an extended measurement during wear period

Misplacement Study Group

Wear AFGen1 device in misplaced position compared to wearing device in standard position as directed by instructions for use

ECG co-measurement

Intervention Type DEVICE

Measure ECG with 12 lead device at same time that AFGen1 is monitoring ECG

Interventions

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ECG co-measurement

Measure ECG with 12 lead device at same time that AFGen1 is monitoring ECG

Intervention Type DEVICE

Periodic ECG triggered measurement

Subject triggers AFGen1 to perform an extended measurement during wear period

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 instructions 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
8. Known or suspected to be pregnant
9. Student or employee of TriVirum

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes