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

NCT06071754 | Completed Results FDA Device

• 1 other identifier: ECGV0001
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Healthy; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

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

  Single Lead ECG, similar to lead I, intended to be used for Heart Rate measurement and AFib detection

  Approximately 30 minutes

Study Arms (1)

INVSENSOR00057

EXPERIMENTAL

All subjects are enrolled into this arm and will have ECG measurements obtained

Device: Masimo INVSENSOR00057

Interventions

Masimo INVSENSOR00057 DEVICE

Masimo INVSENSOR00057 will be used to collect electrocardiogram measurements.

INVSENSOR00057

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (4)

Masimo Clinical Lab

Irvine, California, 92618, United States

Location

PCA Cardiology

Laguna Hills, California, 92653, United States

Location

Cone Health

Greensboro, North Carolina, 27401, United States

Location

Medication Management

Greensboro, North Carolina, 27405, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chelsea Frank
• Organization: Masimo Corporation

clinicalresearchdept@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: October 6, 2023
• Study Start: September 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: October 31, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-10

Locations

US (4)