NCT06071754Completed
Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
Source: ClinicalTrials.gov · Last updated 31 Oct 2025
Brief summary (registry, in English)
The objective of this study is to validate the performance of the electrocardiogram (ECG) function of the Masimo INVSENSOR00057 against contemporaneous measurements
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 365 (actual)
- First submitted
- 18 Sept 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- Masimo Corporation
- Diseases
- Atrial fibrillation
- NCT number
- NCT06071754
What you commit to
- Study type: Interventional
- Participants enrolled: 365
- From 1 Sept 2023 to the primary completion date, 30 Apr 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects previously diagnosed with non-atrial fibrillation cardiac arrhythmia.
Other illness
- 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.
Other
- 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 not suitable for the investigation at the discretion of the investigator or the clinical team
Who the study is looking for
- 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.
Age in the registry: 22 years to - · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medication Management Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| Cone Health Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| Masimo Clinical Lab Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| PCA Cardiology Coordinator of this site? Confirm its status | Laguna Hills | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.