N/A
Completed N=139
Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)
Source: ClinicalTrials.gov NCT05472012 ↗Enrolled (actual)
139
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function — 96.97 % of true positive
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function |
96.97 | — |
| PRIMARY Specificity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function |
100 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05472012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.