NCT05472012

Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)

Completed NA Results posted Last updated 22 May 2025

What this trial tests

NA trial testing INVSENSOR00057 in Atrial Fibrillation in 139 participants. Completed in 16 December 2023.

Timeline

25 July 2022

Primary endpoint
16 December 2023

16 December 2023

Quick facts

Lead sponsor	Masimo Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	139
Start date	25 July 2022
Primary completion	16 December 2023
Estimated completion	16 December 2023
Sites	1 location across United States

Drugs / interventions tested

• INVSENSOR00057

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Masimo Corporation — full company profile →

Who can join

18 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function Primary · 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.

Group	Value	95% CI
INVSENSOR00057	96.97

Specificity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function Primary · 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.

Group	Value	95% CI
INVSENSOR00057	100

Adverse events — posted to ClinicalTrials.gov

Time frame: 1-5 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

INVSENSOR00057

Serious: 0/139 (0%)

Deaths: 0/139

Other adverse events (1 terms — click to expand)

Reaction	System	INVSENSOR00057
Arm Cramp	Injury, poisoning and procedural complications	—

Data from ClinicalTrials.gov NCT05472012 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.