Afib, Arrhythmia Atrial, Arrhythmias, Cardiac, Arrhythmias Paroxysmal, Atrial Fibrillation, Irregular Heart Beat, Paroxysmal Atrial Fibrillation
Conditions
Brief summary
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
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.
Interventions
DEVICEAFGen1 Device Wear Test
Participant wears the device for 7 days
DEVICEAFGen 1 Device Single Use
Participant wears the device in conjunction with a standard ECG
Sponsors
TriVirum, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Evaluation | 7 days | For the quantitative evaluation of the mean and standard deviation of the QRS correlations for all study subjects and for the end of the wear period for those relevant subjects, the mean cor- relation coefficient must be greater than 0.95 and standard deviation must be less than 0.05 to validate a 95% confidence interval with significant factor of assurance. |
| Qualitative Equivalence Evaluation | 7 days | For the qualitative equivalence evaluation according to the two cardiologists the confirmation of equivalence must be greater than 95%. |
| Adhesive performance | 7 days | For the adhe sive performance element of the stud y; t he overall average wear time for the de- vice must be greater than 5 days |
Countries
United States
Outcome results
None listed