CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 139 enrolled
Drug / intervention
INVSENSOR00057device
Likely dose
Not stated in record
Key inclusion· 2
  • ✓Age 18 years or older
  • ✓Confirmed active atrial fibrillation at enrollment
Key exclusion· 3
  • ✕Concurrent active arrhythmias (e.g., PVCs, bradycardia)
  • ✕Allergy to adhesives or ECG gel
  • ✕Non-intact skin at device placement site

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05472012
NCT05472012N/ACompleted
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Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)

Masimo Corporation·interventional·Posted Jul 25, 2022·Updated May 22, 2025

In Brief

A clinical study evaluating INVSENSOR00057 for Atrial Fibrillation. Completed, enrolled 139 participants across 1 site.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedJul 25, 2022
Enrollment StartJul 25, 2022
Primary CompletionDec 16, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 3.9 years ago

Interventions

INVSENSOR00057device

Noninvasive wearable health monitoring device