Actively Recruiting
Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
Led by Masimo Corporation · Updated on 2025-10-31
120
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Masimo Corporation
Irvine, California, United States, 92618
Actively Recruiting
Research Team
A
Ahmed Alghazi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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