Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Masimo Corporation
- Enrollment
- 139
- Locations
- 2
- Primary Endpoint
- Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subject is 18 years of age or older.
- •Subject is confirmed to have active atrial fibrillation at the time of enrollment.
Exclusion Criteria
- •Subject is confirmed to have concurrent active arrhythmias (e.g., PVCs, bradycardia, etc.) at the time of enrollment.
- •Subject is allergic to adhesives or ECG gel.
- •Subject whose skin is not intact in or at the vicinity of the device placement site.
Outcomes
Primary Outcomes
Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function
Time Frame: 1-5 hours
Afib detection accuracy will be determined by analyzing the sensitivity of INVSENSOR00057 Afib detection function when compared to data collected using a FDA-cleared ECG monitor.
Specificity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function
Time Frame: 1-5 hours
Afib detection accuracy will be determined by analyzing the specificity of INVSENSOR00057 Afib detection function when compared to data collected using a FDA-cleared ECG monitor.
Secondary Outcomes
No secondary outcomes reported