Atrial FibrillationCS3NCT06335498
Further Study of AFGen1 Clinical Performance
An observational study of Atrial Fibrillation and Afib, run by TriVirum, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Afib, ECG
- What is being tested?
- ECG co-measurement and Periodic ECG triggered measurement
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2024to 19 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study shall involve up to twenty (20) participants divided into 2 cohorts. The first study cohort will comprise up to fifteen (15) participants (at least 5 male and 5 female) who will wear the device for 7 days. The second cohort of five (5) participants will participate in the misplacement part of the study
Who may be able to join
- 1. 18+ willing to sign the consent form
Who cannot join
- 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
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- Planned to undergo a MRI during the course of the study duration
- Known or suspected to be pregnant
- Student or employee of TriVirum
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Further Study of the Clinical Performance of AFGen1
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.
Read the detailed description
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
- Atrial Fibrillation, Afib, ECG
- Being tested
- ECG co-measurement, Periodic ECG triggered measurement
- Keywords
- ECG signal quality
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG co-measurementDevice
Measure ECG with 12 lead device at same time that AFGen1 is monitoring ECG
Periodic ECG triggered measurementDevice
Subject triggers AFGen1 to perform an extended measurement during wear period
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: ECG co-measurement; Device: Periodic ECG triggered measurement | |
| Misplacement Study Group | Wear AFGen1 device in misplaced position compared to wearing device in standard position as directed by instructions for use Receives: Device: ECG co-measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bland-Altman Comparison
The waveform characteristics for both the 7- day wear and misplacement elements of this study, the limits of agreement (LoA) from the Bland-Altman analyses shall not exceed the the maximum allowed clinically significant difference between methods i.e. 80ms for R-R. 0.2 mV for R-peak amplitude) for 95% of the subjects on a per-subject basis.
Measured: 1 day
Qualitative Evaluation
For the qualitative equivalence evaluation according to the two cardiologists confirmation of equivalence must be greater than 95%.
Measured: 1 day
Adhesive performance
The overall average wear time for the device must be greater than 7-days.
Measured: 7 to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start2 Apr 2024
- Primary completion12 Apr 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriVirum, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allison Willis, BSN RN, Principal investigator, Unafilliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335498
- Sponsor's protocol ID
- 130-0008P
- Acronym
- CS3
- Status last verified
- Jun 2024
- First submitted
- 21 Mar 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Further Study of the Clinical Performance of AFGen1
- ClinicalTrials.gov ID
- NCT06335498
- Acronym / sponsor ID
- CS3 / 130-0008P
- Conditions
- Atrial Fibrillation, Afib, ECG
- Keywords
- ECG signal quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- TriVirum, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wear AFGen1 for at least 7 days | – | Device: ECG co-measurement, Device: Periodic ECG triggered measurementWear 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 |
| Misplacement Study Group | – | Device: ECG co-measurementWear AFGen1 device in misplaced position compared to wearing device in standard position as directed by instructions for use |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study shall involve up to twenty (20) participants divided into 2 cohorts. The first study cohort will comprise up to fifteen (15) participants (at least 5 male and 5 female) who will wear the device for 7 days. The second cohort of five (5) participants will participate in the misplacement part of the study
Key inclusion criteria (1 listed)
- 1. 18+ willing to sign the consent form
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG co-measurementMeasure ECG with 12 lead device at same time that AFGen1 is monitoring ECG | Device | Misplacement Study Group, Wear AFGen1 for at least 7 days |
| Periodic ECG triggered measurementSubject triggers AFGen1 to perform an extended measurement during wear period | Device | Wear AFGen1 for at least 7 days |
Primary outcome
Bland-Altman Comparison
Time frame: 1 day
The waveform characteristics for both the 7- day wear and misplacement elements of this study, the limits of agreement (LoA) from the Bland-Altman analyses shall not exceed the the maximum allowed clinically significant difference between methods i.e. 80ms for R-R. 0.2 mV for R-peak amplitude) for 95% of the subjects on a per-subject basis.
Qualitative Evaluation
Time frame: 1 day
For the qualitative equivalence evaluation according to the two cardiologists confirmation of equivalence must be greater than 95%.
Adhesive performance
Time frame: 7 to 10 days
The overall average wear time for the device must be greater than 7-days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Willis, BSN RN principal investigator
Unafilliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Afib, run by TriVirum, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bland-Altman Comparison (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.