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Validation Study of Frontier X Plus (FX+) Device

NCT06471764 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2024-06-24

No results posted yet for this study

Summary

The main objective of this study is to validate the specificity and sensitivity of FX+ detecting atrial fibrillation (AF) in both AF and non-AF subjects using a comparative approach, which involves using both a US FDA-cleared gold standard 12-lead and a consumer device which stores ECG (FX2 consumer model used to store the ECG for analysis retrospectively).

The results obtained from this clinical investigation will serve as evidence for larger clinical investigation designs for this non-invasive and fully mobile method of continuous AF measurement in the adult population, including those with known or unknown cases of AF. The ultimate goal of this study is to establish the effectiveness of this novel approach in detecting and monitoring AF, which could potentially revolutionize the field of remote cardiac monitoring and improve the quality of care for patients with AF and other cardiac arrhythmias.

Conditions

Interventions

DEVICE

FX+ and 12-Lead ECG Recording

While lying down, subjects will wear the FX+, a chest strap device which will measure cardiac electrical activity to generate a continuous heart rate measurement. Simultaneously, electrodes for the 12-Lead ECG will be placed on the chest and arms/legs to record the electrical activity. Two 30-second recordings from the FX+ will be taken simultaneously with the 12-lead ECG with no more than a 3-minute interval between the two recordings.

Sponsors & Collaborators

  • University of Rochester

    collaborator OTHER

  • Fourth Frontier Technologies Pvt Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-01-20
Completion
2025-04-20

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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 NCT06471764 on ClinicalTrials.gov