Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)

Masimo

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: INVSENSOR00057

Study type: Interventional

Funder types: Industry

Identifiers

NCT05472012

ROBI0001

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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139 participants in 1 patient group

INVSENSOR00057

Experimental group

Description:

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

Treatment:

Device: INVSENSOR00057