Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)
Not Applicable
Completed
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT05472012
- Lead Sponsor
- Masimo Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 139
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function 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 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Site 1
🇺🇸Jackson, Tennessee, United States