Checking Masimo's irregular heartbeat detection in adults without heart disease

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

This will test whether Masimo's finger and wrist devices can correctly detect irregular heartbeats in adults without known heart disease.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Masimo Corporation (industry)
• Locations: 1 site (Irvine, California)
• Trial ID: NCT07223164 on ClinicalTrials.gov

What this trial studies

Adults aged 18–80 without known cardiovascular disease will wear Masimo's finger (SET) and wrist (W1) devices while simultaneous reference ECG recordings are taken with the Masimo Radius VSM. The study measures the specificity of the Irregular Heartbeat Detection algorithm separately for the finger and wrist form factors. Participants with pregnancy, breastfeeding, skin conditions at sensor sites, or nail coverings that interfere with sensors are excluded, and materials are provided in English. Device outputs will be compared to the reference ECG to determine how often the algorithm correctly identifies non-arrhythmic rhythms.

Who should consider this trial

Good fit: Adults 18 to 80 years old without known cardiac disease who can read English and have no skin or nail issues at sensor sites are ideal candidates.

Not a fit: People with known cardiac disease, pregnancy or breastfeeding, skin or nail conditions that prevent proper sensor placement, or those unable to read English are unlikely to benefit from this specific validation.

Why it matters

Potential benefit: If successful, the devices could provide more reliable noninvasive detection of irregular heartbeats in people without known heart disease, supporting earlier recognition and reassurance.

How similar studies have performed: Other wearable PPG-based algorithms (for example, Apple Watch and Fitbit) have shown promise in detecting irregular heart rhythms, but performance varies by device and requires device-specific validation.

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.
* 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.

Where this trial is running

Irvine, California

• Masimo Corporation — Irvine, California, United States (RECRUITING)

Study contacts

• Study coordinator: Ahmed Alghazi

Conditions: Healthy