Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease

ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMasimo Corporation

About this trial

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

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Masimo SET® and Masimo W1®

Treatment groups

120 Participants
are divided into 1 treatment group

Sponsors and collaborators