Trial Outcomes & Findings for Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection (NCT NCT05476250)

Last Updated: 2025-05-13

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

1-5 hours

Results posted on

2025-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	120
Overall Study COMPLETED	99
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Masimo INVSENSOR00057 n=99 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057. INVSENSOR00057: Noninvasive wearable health monitoring device
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	98 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	27 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	19 Participants n=5 Participants
Region of Enrollment United States	99 participants n=5 Participants

PRIMARY outcome

Timeframe: 1-5 hours

Population: 1 subject not analyzed due to EDC error.

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.

Outcome measures

Outcome measures
Measure	Masimo INVSENSOR00057 n=98 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057. INVSENSOR00057: Noninvasive wearable health monitoring device
Specificity of Masimo INVSENSOR00057 Atrial Fibrillation Detection Function	100 % of true negatives

Adverse Events

Masimo 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

Ahmed Alghazi

Masimo Coporation

Phone: 949-297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place