Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)
1 other identifier
interventional
139
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Jul 2022
Shorter than P25 for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2022
CompletedFirst Posted
Study publicly available on registry
July 25, 2022
CompletedStudy Start
First participant enrolled
July 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2023
CompletedResults Posted
Study results publicly available
May 22, 2025
CompletedMay 22, 2025
May 1, 2025
1.4 years
July 21, 2022
May 6, 2025
May 6, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function
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.
1-5 hours
Specificity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function
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.
1-5 hours
Study Arms (1)
INVSENSOR00057
EXPERIMENTALAll subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057 device.
Interventions
Eligibility Criteria
You may qualify if:
- Subject is 18 years of age or older.
- Subject is confirmed to have active atrial fibrillation at the time of enrollment.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Site 1
Jackson, Tennessee, 38301, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chelsea Frank
- Organization
- Masimo
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2022
First Posted
July 25, 2022
Study Start
July 25, 2022
Primary Completion
December 16, 2023
Study Completion
December 16, 2023
Last Updated
May 22, 2025
Results First Posted
May 22, 2025
Record last verified: 2025-05