Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
Purpose
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
Condition
- Healthy
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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 |
|
Recruiting Locations
Masimo Corporation
Irvine 5359777, California 5332921 92618
Irvine 5359777, California 5332921 92618
More Details
- NCT ID
- NCT07223164
- Status
- Recruiting
- Sponsor
- Masimo Corporation