Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
Not Applicable
Completed
- Conditions
- HealthyAtrial Fibrillation
- Registration Number
- NCT06071754
- Lead Sponsor
- Masimo Corporation
- Brief Summary
The objective of this study is to validate the performance of the electrocardiogram (ECG) function of the Masimo INVSENSOR00057 against contemporaneous measurements
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 365
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057 Approximately 30 minutes Single Lead ECG, similar to lead I, intended to be used for Heart Rate measurement and AFib detection
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Masimo Clinical Lab
🇺🇸Irvine, California, United States
PCA Cardiology
🇺🇸Laguna Hills, California, United States
Cone Health
🇺🇸Greensboro, North Carolina, United States
Medication Management
🇺🇸Greensboro, North Carolina, United States