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Clinical Performance of the AFGen1 Device Over a 7-day Period

NCT05295056 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2023-09-28

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation
  • Afib
  • Irregular Heart Beat
  • Arrhythmias, Cardiac
  • Arrhythmia Atrial
  • Arrhythmias Paroxysmal
  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

AFGen1 Device Wear Test

Participant wears the device for 7 days

DEVICE

AFGen 1 Device Single Use

Participant wears the device in conjunction with a standard ECG

Sponsors & Collaborators

  • TriVirum, Inc.

    lead INDUSTRY

Eligibility

Min Age
65 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-12
Primary Completion
2023-08-25
Completion
2023-08-25
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05295056 on ClinicalTrials.gov