Status:
COMPLETED
Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
Lead Sponsor:
Masimo Corporation
Conditions:
Healthy
Atrial Fibrillation
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The objective of this study is to validate the performance of the electrocardiogram (ECG) function of the Masimo INVSENSOR00057 against contemporaneous measurements
Eligibility Criteria
Inclusion
- Subject is 22 years of age or older
- Subject is comfortable to read and communicate in English\*
- Subject belongs to one of two groups:
- Subjects without any prior arrhythmia diagnosis presenting in normal sinus rhythm (Group1)
- Subjects with history of paroxysmal or persistent atrial fibrillation presenting in atrial fibrillation (Group 2) \*This is to ensure the subject can provide informed consent (as Masimo INVSENSOR00057 ECG study materials are currently available in English only) and can comply with study procedures.
Exclusion
- Subjects who are physically unable to wear a wristwatch
- Subjects whose skin is not intact (e.g., has open wounds, has inflamed tattoos or piercings, has visible healing wounds) in or at the vicinity of the device placement site.
- Subjects with an implantable defibrillator or cardiac pacing device.
- Subjects with a skin condition which would preclude proper ECG electrode placement..
- Subjects with known allergic reactions to adhesive tapes or ECG gel.
- Subjects previously diagnosed with non-atrial fibrillation cardiac arrhythmia.
- Subjects not suitable for the investigation at the discretion of the investigator or the clinical team
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
365 Patients enrolled
Trial Details
Trial ID
NCT06071754
Start Date
September 1 2023
End Date
April 30 2024
Last Update
October 31 2025
Active Locations (4)
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1
Masimo Clinical Lab
Irvine, California, United States, 92618
2
PCA Cardiology
Laguna Hills, California, United States, 92653
3
Cone Health
Greensboro, North Carolina, United States, 27401
4
Medication Management
Greensboro, North Carolina, United States, 27405