Clinical Performance of the AFGen1 Device Over a 7-day Period
NCT ID: NCT05295056
Last Updated: 2023-09-28
Study Results
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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COMPLETED
38 participants
OBSERVATIONAL
2022-05-12
2023-08-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Permanent atrial fibrillation
Known to have permanent atrial fibrillation
AFGen1 Device Wear Test
Participant wears the device for 7 days
Healthy control
Healthy controls
AFGen1 Device Wear Test
Participant wears the device for 7 days
AFGen 1 Device Single Use
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
AFGen 1 Device Single Use
Participant wears the device in conjunction with a standard ECG
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
65 Years
90 Years
ALL
No
Sponsors
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TriVirum, Inc.
INDUSTRY
Responsible Party
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Locations
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Clayton Sleep Institute
St Louis, Missouri, United States
Countries
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Other Identifiers
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AFib-Chek-001
Identifier Type: -
Identifier Source: org_study_id
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