Healthy
Conditions
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.
Interventions
DEVICEINVSENSOR00057
Noninvasive wearable health monitoring device
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Masimo INVSENSOR00057 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057.
INVSENSOR00057: Noninvasive wearable health monitoring device | 99 |
| Total | 99 |
Baseline characteristics
| Characteristic | Masimo INVSENSOR00057 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 98 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 27 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 99 participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 120 |
| other Total, other adverse events | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 |
Outcome results
Primary
Specificity of Masimo INVSENSOR00057 Atrial Fibrillation Detection Function
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.
Time frame: 1-5 hours
Population: 1 subject not analyzed due to EDC error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Masimo INVSENSOR00057 | Specificity of Masimo INVSENSOR00057 Atrial Fibrillation Detection Function | 100 % of true negatives |