Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)

Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)

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.

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.