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NCT07223164
Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
Conditions: Healthy
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 120
Sponsor: Masimo Corporation
Location: Masimo Corporation Irvine California
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 be evaluated independently of one another
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07223164). StuddyBuddy aggregates publicly available trial information.