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

October 29, 2025 updated by: Masimo Corporation
The objective of this study is to validate the performance of the electrocardiogram (ECG) function of the Masimo INVSENSOR00057 against contemporaneous measurements

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

365

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92618
        • Masimo Clinical Lab
      • Laguna Hills, California, United States, 92653
        • PCA Cardiology
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Cone Health
      • Greensboro, North Carolina, United States, 27405
        • Medication Management

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INVSENSOR00057
All subjects are enrolled into this arm and will have ECG measurements obtained
Device: Masimo INVSENSOR00057
Masimo INVSENSOR00057 will be used to collect electrocardiogram measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
Time Frame: Approximately 30 minutes
Single Lead ECG, similar to lead I, intended to be used for Heart Rate measurement and AFib detection
Approximately 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masimo Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Estimated)

October 31, 2025

Last Update Submitted That Met QC Criteria

October 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECGV0001

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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