Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection

Stopped early · Not applicable

Conditions studied: Healthy

In brief

This study is designed to validate the performance of Masimo INVSENSOR00057 in detecting atrial fibrillation. The noninvasive ECG measurements will be compared to results obtained from an FDA-cleared ECG monitor.

Key facts

Study ID

NCT05476250

Run by

Masimo Corporation

People needed

120

Starts

2022-08-01

Expected to finish

2022-08-10

Last updated by the study team

2025-05-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The subject is 18 to 80 years of age.
• Subject can read and communicate in English.
• Subject's cardiac rhythm shall be Normal Sinus Rhythm or Atrial Fibrillation (Afib). This determination will be made using FDA cleared 3-lead ECG which will label subject's cardiac rhythm as such.

You may not qualify if…

• Subject has open wounds, inflamed tattoos or piercings on the area of device placement, and/or has any visible healing wounds that the investigator and/or medical professional determines may place them at an increased risk for participation.
• 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 it is running

• Masimo Corporation — Irvine, California, United States

Full record on ClinicalTrials.gov

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