Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-25

Study Completion Date

2023-12-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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INVSENSOR00057

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

Group Type EXPERIMENTAL

INVSENSOR00057

Intervention Type DEVICE

Noninvasive wearable health monitoring device

Interventions

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INVSENSOR00057

Noninvasive wearable health monitoring device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject is 18 years of age or older.
* Subject is confirmed to have active atrial fibrillation at the time of enrollment.

Exclusion Criteria

* Subject is confirmed to have concurrent active arrhythmias (e.g., PVCs, bradycardia, etc.) at the time of enrollment.
* Subject is allergic to adhesives or ECG gel.
* Subject whose skin is not intact in or at the vicinity of the device placement site.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes