Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057

Completed · Not applicable

Conditions studied: Healthy, Atrial Fibrillation

In brief

The objective of this study is to validate the performance of the electrocardiogram (ECG) function of the Masimo INVSENSOR00057 against contemporaneous measurements

Key facts

Study ID

NCT06071754

Run by

Masimo Corporation

People needed

365

Starts

2023-09-01

Expected to finish

2024-04-30

Last updated by the study team

2025-10-31

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is 22 years of age or older
• Subject is comfortable to read and communicate in English*
• Subject belongs to one of two groups:
• Subjects without any prior arrhythmia diagnosis presenting in normal sinus rhythm (Group1)
• Subjects with history of paroxysmal or persistent atrial fibrillation presenting in atrial fibrillation (Group 2) *This is to ensure the subject can provide informed consent (as Masimo INVSENSOR00057 ECG study materials are currently available in English only) and can comply with study procedures.

You may not qualify if…

• Subjects who are physically unable to wear a wristwatch
• Subjects whose skin is not intact (e.g., has open wounds, has inflamed tattoos or piercings, has visible healing wounds) in or at the vicinity of the device placement site.
• Subjects with an implantable defibrillator or cardiac pacing device.
• Subjects with a skin condition which would preclude proper ECG electrode placement..
• Subjects with known allergic reactions to adhesive tapes or ECG gel.
• Subjects previously diagnosed with non-atrial fibrillation cardiac arrhythmia.
• Subjects not suitable for the investigation at the discretion of the investigator or the clinical team

Where it is running

• Masimo Clinical Lab — Irvine, California, United States
• PCA Cardiology — Laguna Hills, California, United States
• Cone Health — Greensboro, North Carolina, United States
• Medication Management — Greensboro, North Carolina, United States

Full record on ClinicalTrials.gov

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