NCT07223164CompletedNot Applicable
Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Masimo Corporation
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Specificity of Masimo SET®
Study Overview
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 be evaluated independently of one another
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Specificity of Irregular Heartbeat Detection
Experimental
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
Intervention: Masimo SET® and Masimo W1® (Device)
Outcomes
Primary Outcomes
Specificity of Masimo SET®
Time Frame: 1-2 hours
Specificity of Masimo W1®
Time Frame: 1-2 hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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