Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection

NCT05476250 | Terminated Results FDA Device

• 1 other identifier: CIP-1022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Specificity of Masimo INVSENSOR00057 Atrial Fibrillation Detection Function

  Specificity refers to the ability of Masimo INVSENSOR00057 to correctly identify individuals who do not have atrial fibrillation. High specificity is important in minimizing false positives.

  1-5 hours

Study Arms (1)

INVSENSOR00057

EXPERIMENTAL

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057.

Device: INVSENSOR00057

Interventions

INVSENSOR00057 DEVICE

Noninvasive wearable health monitoring device

INVSENSOR00057

Eligibility Criteria

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

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.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Ahmed Alghazi
• Organization: Masimo Coporation

studies@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: Yes

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: July 25, 2022
• First Posted: July 27, 2022
• Study Start: August 1, 2022
• Primary Completion: August 10, 2022
• Study Completion: August 10, 2022
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-04

Locations

US (1)