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OpenTrials
Completed

NCT Number: NCT07223164

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

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

Completed

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masimo Corporation

Irvine, California, 92618, United States

Who can participate

Healthy volunteers accepted: Yes

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

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 informed consent and can comply with study procedures (as study material are currently available in English only).

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 ECG 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.

Treatment and study plan

Masimo SET® and Masimo W1®

Device

Pulse oximeter and wrist wearable device

Primary outcomes

  1. Specificity of Masimo SET®

    Time frame: 1-2 hours

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 31, 2025
Registry last updated
Jul 30, 2026

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.

Published trials that share one or more normalized conditions with this study.