NCT05476250

Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Masimo Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	INVSENSOR00057	Noninvasive wearable health monitoring device

Timeline

• Start date: 2022-08-01
• Primary completion: 2022-08-10
• Completion: 2022-08-10
• First posted: 2022-07-27
• Last updated: 2025-05-13
• Results posted: 2025-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study