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Completed

NCT Number: NCT06071754

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

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

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Key information

Conditions

Healthy Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masimo Clinical Lab, Irvine, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Masimo INVSENSOR00057

Device

Masimo INVSENSOR00057 will be used to collect electrocardiogram measurements.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 6, 2023
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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