Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
This study is designed to validate the performance of Masimo Irregular Heartbeat Detection algorithm using Masimo SET® in detecting atrial fibrillation. The measurements will be compared to results obtained from Masimo Radius VSM®.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
California
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Irvine, California, United States, 92618
- Masimo Corporation
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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Subject is 18 to 80 years of age.
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Comfortable to read and communicate in English.*
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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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Specificity of Irregular Heartbeat Detection (using Masimo SET®)
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo SET® sensor. |
Pulse oximeter device |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Specificity Measures the % of True Negatives for Atrial Fibrillation Detection in Participants With Normal Sinus Rhythm.
Time Frame: 1-2 hours
|
Specificity was calculated as the percentage of participants with normal sinus rhythm correctly identified by the Irregular Heartbeat Detection algorithm (using Masimo SET®) as not having atrial fibrillation (true negatives). Specificity = True Negatives ÷ (True Negatives + False Positives) × 100%. |
1-2 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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