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Validation Study of Frontier X Plus (FX+) Device
Sponsor: Fourth Frontier Technologies Pvt Ltd.
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.
Official title: Validation Study of Frontier X Plus (FX+) Device: Recording an Electrocardiogram (ECG) for Retrospective Rhythm Analysis in Patients with and Without Atrial Fibrillation (AF) in US Subjects
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
125
Start Date
2024-07-01
Completion Date
2025-04-20
Last Updated
2024-06-24
Healthy Volunteers
Yes
Conditions
Interventions
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.