ClinicalTrials.gg
CompletedNCT07223164Updated Jul 30, 2026

Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease

An interventional study of Masimo SET® and Masimo W1® in Healthy, sponsored by Masimo Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Masimo Corporation (part of Danaher Corporation) · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was Oct 2025, 1 year ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Specificity measure of performance of the Irregular Heartbeat Detection algorithm (evaluated for the finger and wrist form factors) against the Masimo Radius VSM® reference ECG. Each form factor will be evaluated independently of one another

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Masimo Corporation is the lead sponsor of 105 studies on the registry; 1 is open to participants now.

Of its 79 completed or terminated interventional studies of FDA-regulated products, 66 (84%) have results posted.

First submitted before Masimo Corporation became part of Danaher Corporation.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject is 18 to 80 years of age.
  • Comfortable to read and communicate in English.*
  • Subject passes the health assessment conducted by qualified study personnel, confirming they are in adequate health to participate in the required procedures

    • This is to ensure the participant can provide and can comply with study procedures (as study material are currently available in English only).

Exclusion criteria

Exclusion Criteria:

  • Subject currently has a known cardiac disease condition.
  • Subject is pregnant or breastfeeding.
  • Subjects with a skin condition affecting the digits/chest, where the sensors are applied which would interfere with the path of lights (e.g., psoriasis, vitiligo, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown) or sensor adhesion.
  • Skin condition which would preclude proper placement.
  • Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied, who opt not to remove them.
  • Subject is allergic to any supplies used in the study (e.g., ECG gel, adhesives).
  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    Specificity of Irregular Heartbeat Detection

    Specificity measure of performance of the Irregular Heartbeat Detection algorithm (evaluated for the finger and wrist form factors) against the Masimo Radius VSM® reference ECG. Each form factor will be evaluated independently of one another

    Device: Masimo SET® and Masimo W1®

Interventions

  • DeviceMasimo SET® and Masimo W1®

    Pulse oximeter and wrist wearable device

06

What researchers measure

Primary outcomes

  1. Specificity of Masimo SET®

    Time frame: 1-2 hours

07

Study locations

1 site
  • Masimo Corporation
    Irvine, California 92618, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07223164
Lead sponsor
Masimo Corporation
Responsible party
Sponsor
First posted
Oct 31, 2025
Start date
Oct 21, 2025
Primary completion
Oct 31, 2025
Completion
Oct 31, 2025
Last update
Jul 30, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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