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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Device: Masimo SET® and Masimo W1®

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Alghazi; Phone Number: 949-297-7000; Email: studies@masimo.com

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Recruiting
      • Masimo Corporation
      • Contact: Ahmed Alghazi; Phone Number: 949-297-7000; Email: studies@masimo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Specificity of Irregular Heartbeat Detection; 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®; Pulse oximeter and wrist wearable device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Specificity of Masimo SET®	1-2 hours
Specificity of Masimo W1®	1-2 hours

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 29, 2025
• First Submitted That Met QC Criteria: October 29, 2025
• First Posted (Estimated): October 31, 2025

Study Record Updates

• Last Update Posted (Estimated): October 31, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CIP-1102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes