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OpenTrials
Completed

NCT Number: NCT05472012

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Site 1

Jackson, Tennessee, 38301, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INVSENSOR00057

Device

Noninvasive wearable health monitoring device

Primary outcomes

  1. Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function

    Time frame: 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.

  2. Specificity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 25, 2022
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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