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Trial Outcomes & Findings for Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib) (NCT NCT05472012)

NCT ID: NCT05472012

Last Updated: 2025-05-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

139 participants

Primary outcome timeframe

1-5 hours

Results posted on

2025-05-22

Participant Flow

Participant milestones

Participant milestones
Measure
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
Overall Study
STARTED
139
Overall Study
COMPLETED
139
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
INVSENSOR00057
n=139 Participants
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
Age, Categorical
<=18 years
0 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
n=93 Participants
Age, Categorical
>=65 years
119 Participants
n=93 Participants
Sex: Female, Male
Female
65 Participants
n=93 Participants
Sex: Female, Male
Male
74 Participants
n=93 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=93 Participants
Race (NIH/OMB)
White
134 Participants
n=93 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=93 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
INVSENSOR00057
n=116 Participants
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
Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function
96.97 % of true positive

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
INVSENSOR00057
n=116 Participants
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
Specificity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function
100 % of true negative

Adverse Events

INVSENSOR00057

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
INVSENSOR00057
n=139 participants at risk
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
Injury, poisoning and procedural complications
Arm Cramp
0.72%
1/139 • 1-5 hours

Additional Information

Chelsea Frank

Masimo

Phone: 949-297-7000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place