Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
NCT ID: NCT07223164
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-10-21
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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
Masimo SET® and Masimo W1®
Pulse oximeter and wrist wearable device
Interventions
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Masimo SET® and Masimo W1®
Pulse oximeter and wrist wearable device
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
Yes
Sponsors
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Masimo Corporation
INDUSTRY
Responsible Party
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Locations
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Masimo Corporation
Irvine, California, United States
Countries
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Central Contacts
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Facility Contacts
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Ahmed Alghazi
Role: primary
Other Identifiers
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CIP-1102
Identifier Type: -
Identifier Source: org_study_id