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

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

Recruiting
18-80 years
All
Phase N/A

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Overview

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

Eligibility

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.

Study details
    Healthy

NCT07223164

Masimo Corporation

1 November 2025

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