Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection

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

TERMINATED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2022-08-10

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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Healthy

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.

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

* The subject is 18 to 80 years of age.
* Subject can read and communicate in English.
* Subject's cardiac rhythm shall be Normal Sinus Rhythm or Atrial Fibrillation (Afib). This determination will be made using FDA cleared 3-lead ECG which will label subject's cardiac rhythm as such.

Exclusion Criteria

* Subject has open wounds, inflamed tattoos or piercings on the area of device placement, and/or has any visible healing wounds that the investigator and/or medical professional determines may place them at an increased risk for participation.
* Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes