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New ECG gadget put to the test for spotting irregular heartbeats

NCT ID NCT06071754

Diagnosis Sponsor: Masimo Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new device called Masimo INVSENSOR00057 that records a single-lead ECG, similar to a standard lead I. Researchers compared its heart rate and atrial fibrillation detection against standard measurements in 365 adults, including healthy people and those with AFib. The goal was to see if the device works accurately enough for everyday use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Masimo INVSENSOR00057 (ECG monitoring device)
What this could lead to
If successful, this device could provide a reliable way to detect atrial fibrillation and measure heart rate, potentially improving early diagnosis.
What could go wrong
This is a completed validation study, not a treatment trial. The device may not outperform existing ECG methods, and results may not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

365 people

The number who actually took part.

Started

Sep 2023

Finished

Apr 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation Healthy

Contacts and locations

Locations

  • Cone Health

    Greensboro, North Carolina, 27401, United States

  • Masimo Clinical Lab

    Irvine, California, 92618, United States

  • Medication Management

    Greensboro, North Carolina, 27405, United States

  • PCA Cardiology

    Laguna Hills, California, 92653, United States

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