Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)

Part of paid clinical trials in Jackson, Tennessee.

Sponsor
Masimo Corporation
Study ID
NCT05472012
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • INVSENSOR00057 — DEVICE
    Noninvasive wearable health monitoring device

Study Details

This study is designed to validate the performance of Masimo INVSENSOR00057 in detecting atrial fibrillation. The noninvasive ECG measurements will be compared to results obtained from an FDA-cleared ECG monitor.

Key Dates

Start date
Jul 25, 2022
Status verified
May 2025
Primary completion
Dec 16, 2023
Completion
Dec 16, 2023

Study Design

Enrollment
139 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: INVSENSOR00057
    All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057 device.

Primary Outcome Measure

Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function [ Time Frame: 1-5 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
Site 1JacksonTennessee38301-

Find similar trials in Jackson, TN

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Site 1· Jackson, TN

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