N/A
N=365
Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
Healthy · Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT06071754 ↗Enrolled (actual)
365
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057 — 99.3; 100.0 percent
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Masimo INVSENSOR00057 (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057 |
99.3; 100.0 | — |
Summary
The objective of this study is to validate the performance of the electrocardiogram (ECG) function of the Masimo INVSENSOR00057 against contemporaneous measurements
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06071754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.