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

Masimo

Status

Enrolling

Conditions

Healthy

Treatments

Device: Masimo SET® and Masimo W1®

Study type

Interventional

Funder types

Industry

Identifiers

NCT07223164

CIP-1102

Details and patient eligibility

About

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

Enrollment

120 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.