Atrial Fibrillation
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 No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject is 18 years of age or older. * Subject is confirmed to have active atrial fibrillation at the time of enrollment.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function | 1-5 hours | 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. |
| Specificity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function | 1-5 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| INVSENSOR00057 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057 device.
INVSENSOR00057: Noninvasive wearable health monitoring device | 139 |
| Total | 139 |
Baseline characteristics
| Characteristic | INVSENSOR00057 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 119 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 134 Participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 139 |
| other Total, other adverse events | 1 / 139 |
| serious Total, serious adverse events | 0 / 139 |
Outcome results
Primary
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.
Time frame: 1-5 hours
Population: A total of 23 subjects were excluded from the data analysis based on the protocol criteria. This included individuals whose reference or test ECG did not provide readable waveforms, as determined by medical personnel, and those who appeared to have atrial fibrillation (Afib) at enrollment but provided waveforms that were inconsistent with an Afib diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INVSENSOR00057 | Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function | 96.97 % of true positive |
Primary
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.
Time frame: 1-5 hours
Population: A total of 23 subjects were excluded from the data analysis based on the protocol criteria. This included individuals whose reference or test ECG did not provide readable waveforms, as determined by medical personnel, and those who appeared to have atrial fibrillation (Afib) at enrollment but provided waveforms that were inconsistent with an Afib diagnosis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INVSENSOR00057 | Specificity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function | 100 % of true negative |