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

Masimo

Status

Completed

Conditions

Atrial Fibrillation

Healthy

Treatments

Device: Masimo INVSENSOR00057

Study type

Interventional

Funder types

Industry

Identifiers

NCT06071754

ECGV0001

Details and patient eligibility

About

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

Enrollment

365 patients

Sex

All

Ages

22+ years old

Volunteers

Accepts Healthy Volunteers

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