Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06071754

Enrollment

365

Registered

2023-10-06

Start date

2023-09-01

Completion date

2024-04-30

Last updated

2025-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Healthy

Brief summary

The objective of this study is to validate the performance of the electrocardiogram (ECG) function of the Masimo INVSENSOR00057 against contemporaneous measurements

Interventions

DEVICEMasimo INVSENSOR00057

Masimo INVSENSOR00057 will be used to collect electrocardiogram measurements.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Subject is 22 years of age or older * Subject is comfortable to read and communicate in English\* * Subject belongs to one of two groups: * Subjects without any prior arrhythmia diagnosis presenting in normal sinus rhythm (Group1) * Subjects with history of paroxysmal or persistent atrial fibrillation presenting in atrial fibrillation (Group 2) \*This is to ensure the subject can provide informed consent (as Masimo INVSENSOR00057 ECG study materials are currently available in English only) and can comply with study procedures.

Exclusion criteria

* Subjects who are physically unable to wear a wristwatch * Subjects whose skin is not intact (e.g., has open wounds, has inflamed tattoos or piercings, has visible healing wounds) in or at the vicinity of the device placement site. * Subjects with an implantable defibrillator or cardiac pacing device. * Subjects with a skin condition which would preclude proper ECG electrode placement.. * Subjects with known allergic reactions to adhesive tapes or ECG gel. * Subjects previously diagnosed with non-atrial fibrillation cardiac arrhythmia. * Subjects not suitable for the investigation at the discretion of the investigator or the clinical team

Design outcomes

Primary

Measure	Time frame	Description
Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057	Approximately 30 minutes	Single Lead ECG, similar to lead I, intended to be used for Heart Rate measurement and AFib detection

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	365
Total	365

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Device rhythm classifications not obtained from subjects due to protocol not being completed	9

Baseline characteristics

Characteristic	INVSENSOR00057
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	166 Participants
Age, Categorical Between 18 and 65 years	199 Participants
Race/Ethnicity, Customized Asian	58 Participants
Race/Ethnicity, Customized Black or African American	26 Participants
Race/Ethnicity, Customized Hispanic, Latino or Spanish	55 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants
Race/Ethnicity, Customized Non-Hispanic, Latino or Spanish	259 Participants
Race/Ethnicity, Customized Not Reported	51 Participants
Race/Ethnicity, Customized Other	31 Participants
Race/Ethnicity, Customized White	209 Participants
Sex: Female, Male Female	140 Participants
Sex: Female, Male Male	225 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 365
other Total, other adverse events	0 / 365
serious Total, serious adverse events	0 / 365

Outcome results

Primary