Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)
NCT05472012 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 139
Last updated 2025-05-22
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
Interventions
- DEVICE
-
INVSENSOR00057
Noninvasive wearable health monitoring device
Sponsors & Collaborators
-
Masimo Corporation
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-07-25
- Primary Completion
- 2023-12-16
- Completion
- 2023-12-16
- FDA Device
- Yes
Countries
- United States
Study Locations
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