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

NCT07223164 | Recruiting FDA Device

• 1 other identifier: CIP-1102
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Specificity of Masimo SET®

  1-2 hours

• Specificity of Masimo W1®

  1-2 hours

Study Arms (1)

Specificity of Irregular Heartbeat Detection

EXPERIMENTAL

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

Device: Masimo SET® and Masimo W1®

Interventions

Masimo SET® and Masimo W1® DEVICE

Pulse oximeter and wrist wearable device

Specificity of Irregular Heartbeat Detection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

RECRUITING

Central Study Contacts

Ahmed Alghazi

CONTACT

949-297-7000; studies@masimo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: October 31, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 31, 2025

Record last verified: 2025-10

Locations

US (1)