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

Part of paid clinical trials in Irvine, California.

Sponsor
Masimo Corporation
Study ID
NCT07223164
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Masimo SET® and Masimo W1® — DEVICE
    Pulse oximeter and wrist wearable device

Study Details

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

Key Dates

Start date
Oct 21, 2025
Status verified
Oct 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

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

Primary Outcome Measure

Specificity of Masimo SET® [ Time Frame: 1-2 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Masimo CorporationIrvineCalifornia92618
Ahmed Alghazi
[email protected]
949-297-7000

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By research site
Masimo Corporation· Irvine, CA

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