NCT07223164 Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
| NCT ID | NCT07223164 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Masimo Corporation |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-10-21 |
| Primary Completion | 2026-06-01 |
Trial Parameters
Eligibility Fast-Check
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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
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. *