Status:
RECRUITING
Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
Lead Sponsor:
Masimo Corporation
Conditions:
Healthy
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07223164
Start Date
October 21 2025
End Date
June 1 2026
Last Update
October 31 2025
Active Locations (1)
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1
Masimo Corporation
Irvine, California, United States, 92618