Clinical Performance of AFGen1
Clinical Performance of the AFGen1 Device Over a 7-day Period
1 other identifier
observational
15
1 country
1
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 AFGen1 on human participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2023
CompletedStudy Start
First participant enrolled
October 5, 2023
CompletedFirst Posted
Study publicly available on registry
October 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 24, 2023
CompletedApril 11, 2024
April 1, 2024
1 month
October 4, 2023
April 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (1)
Wear AFGen1
Wear AFGen1 for 7 days. ECG co-measurement with 12 lead device at start and end of wear period
Interventions
Measure ECG with 12 lead device at same time that AFGen1 is monitoring ECG
Eligibility Criteria
The study shall involve 15 participants (approximately equal number of males and females, meeting inclusion and exclusion criteria.
You may qualify if:
- \. 18+ willing to sign the consent form
You may not qualify if:
- Implanted pacemakers
- Implanted cardioverter defibrillators
- Implanted cardiac resynchronization devices
- Potential life-threatening arrythmias
- Physical or mental health conditions that would prevent the person from being able to follow instructions regarding participation in the study
- Open wounds, abraded or irritated skin at the application site
- Planned to undergo a MRI during the course of the study duration
- Known or suspected to be pregnant
- Student or employee of TriVirum
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TriVirum, Inc.lead
Study Sites (1)
4927 Lillian Street
San Diego, California, 92110, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2023
First Posted
October 11, 2023
Study Start
October 5, 2023
Primary Completion
November 5, 2023
Study Completion
November 24, 2023
Last Updated
April 11, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share