Trial Outcomes & Findings for Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057 (NCT NCT06071754)
NCT ID: NCT06071754
Last Updated: 2025-10-31
Results Overview
Single Lead ECG, similar to lead I, intended to be used for Heart Rate measurement and AFib detection
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
365 participants
Primary outcome timeframe
Approximately 30 minutes
Results posted on
2025-10-31
Participant Flow
Participant milestones
| Measure |
INVSENSOR00057
All subjects are enrolled into this arm and will have ECG measurements obtained
Masimo INVSENSOR00057: Masimo INVSENSOR00057 will be used to collect electrocardiogram measurements.
|
|---|---|
|
Overall Study
STARTED
|
365
|
|
Overall Study
COMPLETED
|
356
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
INVSENSOR00057
All subjects are enrolled into this arm and will have ECG measurements obtained
Masimo INVSENSOR00057: Masimo INVSENSOR00057 will be used to collect electrocardiogram measurements.
|
|---|---|
|
Overall Study
Device rhythm classifications not obtained from subjects due to protocol not being completed
|
9
|
Baseline Characteristics
Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
Baseline characteristics by cohort
| Measure |
INVSENSOR00057
n=365 Participants
All subjects are enrolled into this arm and will have ECG measurements obtained
Masimo INVSENSOR00057: Masimo INVSENSOR00057 will be used to collect electrocardiogram measurements.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
199 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
166 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
225 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic, Latino or Spanish
|
55 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, Latino or Spanish
|
259 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
209 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 30 minutesPopulation: Masimo W1 rhythm classifications were not obtained from 9 subjects (3 from the NSR group, 6 from AFib group) due to the subject not completing the protocol.
Single Lead ECG, similar to lead I, intended to be used for Heart Rate measurement and AFib detection
Outcome measures
| Measure |
INVSENSOR00057
n=356 Participants
All subjects are enrolled into this arm and will have ECG measurements obtained
Masimo INVSENSOR00057: Masimo INVSENSOR00057 will be used to collect electrocardiogram measurements.
|
|---|---|
|
Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
Sensitivity
|
99.3 percent
|
|
Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
Specificity
|
100.0 percent
|
Adverse Events
INVSENSOR00057
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place