Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-04-30

Brief Summary

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The objective of this study is to validate the performance of the electrocardiogram (ECG) function of the Masimo INVSENSOR00057 against contemporaneous measurements

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Detailed Description

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Conditions

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Healthy 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 are enrolled into this arm and will have ECG measurements obtained

Group Type EXPERIMENTAL

Masimo INVSENSOR00057

Intervention Type DEVICE

Masimo INVSENSOR00057 will be used to collect electrocardiogram measurements.

Interventions

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Masimo INVSENSOR00057

Masimo INVSENSOR00057 will be used to collect electrocardiogram measurements.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject is 22 years of age or older
* Subject is comfortable to read and communicate in English\*
* Subject belongs to one of two groups:
* Subjects without any prior arrhythmia diagnosis presenting in normal sinus rhythm (Group1)
* Subjects with history of paroxysmal or persistent atrial fibrillation presenting in atrial fibrillation (Group 2) \*This is to ensure the subject can provide informed consent (as Masimo INVSENSOR00057 ECG study materials are currently available in English only) and can comply with study procedures.

Exclusion Criteria

* Subjects who are physically unable to wear a wristwatch
* Subjects whose skin is not intact (e.g., has open wounds, has inflamed tattoos or piercings, has visible healing wounds) in or at the vicinity of the device placement site.
* Subjects with an implantable defibrillator or cardiac pacing device.
* Subjects with a skin condition which would preclude proper ECG electrode placement..
* Subjects with known allergic reactions to adhesive tapes or ECG gel.
* Subjects previously diagnosed with non-atrial fibrillation cardiac arrhythmia.
* Subjects not suitable for the investigation at the discretion of the investigator or the clinical team

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes