Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: INVSENSOR00057

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INVSENSOR00057; All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057 device.	Device: INVSENSOR00057; Noninvasive wearable health monitoring device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function	Afib detection accuracy will be determined by analyzing the sensitivity of INVSENSOR00057 Afib detection function when compared to data collected using a FDA-cleared ECG monitor.	1-5 hours
Specificity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function	Afib detection accuracy will be determined by analyzing the specificity of INVSENSOR00057 Afib detection function when compared to data collected using a FDA-cleared ECG monitor.	1-5 hours

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Actual): December 16, 2023
• Study Completion (Actual): December 16, 2023

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: ROBI0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes