Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection
Not Applicable
Terminated
- Conditions
- Healthy
- Registration Number
- NCT05476250
- Lead Sponsor
- Masimo Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- The subject is 18 to 80 years of age.
- Subject can read and communicate in English.
- Subject's cardiac rhythm shall be Normal Sinus Rhythm or Atrial Fibrillation (Afib). This determination will be made using FDA cleared 3-lead ECG which will label subject's cardiac rhythm as such.
Exclusion Criteria
- Subject has open wounds, inflamed tattoos or piercings on the area of device placement, and/or has any visible healing wounds that the investigator and/or medical professional determines may place them at an increased risk for participation.
- Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Specificity of Masimo INVSENSOR00057 Atrial Fibrillation Detection Function 1-5 hours Specificity refers to the ability of Masimo INVSENSOR00057 to correctly identify individuals who do not have atrial fibrillation. High specificity is important in minimizing false positives.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Masimo Corporation
🇺🇸Irvine, California, United States