Atrial Fibrillation Clinical Trial
Official title:
Clinical Performance of the AFGen1 Device Over a 7-day Period
NCT number | NCT06076798 |
Other study ID # | 130-0006P |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 5, 2023 |
Est. completion date | November 24, 2023 |
Verified date | April 2024 |
Source | TriVirum, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 AFGen1 on human participants.
Status | Completed |
Enrollment | 15 |
Est. completion date | November 24, 2023 |
Est. primary completion date | November 5, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | 4927 Lillian Street | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
TriVirum, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantitative Evaluation | For the quantitative evaluation of the mean and standard deviation of the QRS amplitude, duration, and timing correlations for all study subjects and for the end of the wear period for those relevant subjects, the mean correlation 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.
validate a 95% confidence interval with significant factor of assurance. |
7 days | |
Primary | Adhesive performance | For the adhesive performance element of the study, the overall average wear time for the device must be greater than 5-days. | 7 days |
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