Further Study of AFGen1 Clinical Performance

NCT06335498 | Completed FDA Device

• 1 other identifier: 130-0008P
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 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 further evidence for the clinical performance of AFGen1 on human participants.

Conditions

Atrial Fibrillation; Afib; ECG

Keywords

ECG signal quality

Outcome Measures

Primary Outcomes (3)

• 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.

  1 day

• Qualitative Evaluation

  For the qualitative equivalence evaluation according to the two cardiologists confirmation of equivalence must be greater than 95%.

  1 day

• Adhesive performance

  The overall average wear time for the device must be greater than 7-days.

  7 to 10 days

Study Arms (2)

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

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

Device: ECG co-measurement

Interventions

ECG co-measurement DEVICE

Measure ECG with 12 lead device at same time that AFGen1 is monitoring ECG

Misplacement Study Group; Wear AFGen1 for at least 7 days

Periodic ECG triggered measurement DEVICE

Subject triggers AFGen1 to perform an extended measurement during wear period

Wear AFGen1 for at least 7 days

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

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

Sponsors & Collaborators

• TriVirum, Inc.: lead

Study Sites (1)

1808 49Th St Ct NW

Gig Harbor, Washington, 98335, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Allison Willis, BSN RN

  Unafilliated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: April 2, 2024
• Primary Completion: April 12, 2024
• Study Completion: April 19, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)