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Further Study of AFGen1 Clinical Performance

NCT06335498 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-06-20

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 further evidence for the clinical performance of AFGen1 on human participants.

Conditions

Interventions

DEVICE

ECG co-measurement

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

DEVICE

Periodic ECG triggered measurement

Subject triggers AFGen1 to perform an extended measurement during wear period

Sponsors & Collaborators

  • TriVirum, Inc.

    lead INDUSTRY

Principal Investigators

  • Allison Willis, BSN RN · Unafilliated

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-02
Primary Completion
2024-04-12
Completion
2024-04-19
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 NCT06335498 on ClinicalTrials.gov