HealthyNCT06071754
Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
A study testing Masimo INVSENSOR00057 in people with Healthy and Atrial Fibrillation, run by Masimo Corporation at 4 sites in United States.
Trial summary
The objective of this study is to validate the performance of the electrocardiogram (ECG) function of the Masimo INVSENSOR00057 against contemporaneous measurements Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Atrial Fibrillation
- What is being tested?
- Masimo INVSENSOR00057
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Sep 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cone Health
Greensboro, North Carolina, 27401
Medication Management
Greensboro, North Carolina, 27405
Masimo Clinical Lab
Irvine, California, 92618
PCA Cardiology
Laguna Hills, California, 92653
About this study
The objective of this study is to validate the performance of the electrocardiogram (ECG) function of the Masimo INVSENSOR00057 against contemporaneous measurements
- Conditions
- Healthy, Atrial Fibrillation
- Being tested
- Masimo INVSENSOR00057
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo INVSENSOR00057Device
Masimo INVSENSOR00057 will be used to collect electrocardiogram measurements.
| Study group | Role | What they receive |
|---|---|---|
| INVSENSOR00057 | Experimental | All subjects are enrolled into this arm and will have ECG measurements obtained Receives: Device: Masimo INVSENSOR00057 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
Single Lead ECG, similar to lead I, intended to be used for Heart Rate measurement and AFib detection
Measured: Approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Sep 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071754
- Sponsor's protocol ID
- ECGV0001
- Status last verified
- Oct 2025
- First submitted
- 18 Sep 2023
- Last updated
- 31 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
- ClinicalTrials.gov ID
- NCT06071754
- Acronym / sponsor ID
- ECGV0001
- Conditions
- Healthy, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 6 Oct 2023 (actual)
- Results
- Posted 12 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to validate the performance of the electrocardiogram (ECG) function of the Masimo INVSENSOR00057 against contemporaneous measurements
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INVSENSOR00057 | Experimental | Device: Masimo INVSENSOR00057All subjects are enrolled into this arm and will have ECG measurements obtained |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Masimo INVSENSOR00057Masimo INVSENSOR00057 will be used to collect electrocardiogram measurements. | Device | INVSENSOR00057 |
Primary outcome
Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
Time frame: Approximately 30 minutes
Single Lead ECG, similar to lead I, intended to be used for Heart Rate measurement and AFib detection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Masimo INVSENSOR00057 in people with Healthy and Atrial Fibrillation, run by Masimo Corporation at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057 (time frame: Approximately 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.