Atrial FibrillationNCT05472012

Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)

A study testing INVSENSOR00057 in people with Atrial Fibrillation, run by Masimo Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to validate the performance of Masimo INVSENSOR00057 in detecting atrial fibrillation. The noninvasive ECG measurements will be compared to results obtained from an FDA-cleared ECG monitor. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Atrial Fibrillation
What is being tested?: INVSENSOR00057
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 139 participants
Where: 1 siteUnited States
Study dates: 25 Jul 2022to 16 Dec 2023
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject is 18 years of age or older.
Subject is confirmed to have active atrial fibrillation at the time of enrollment.

Who cannot join

Subject is confirmed to have concurrent active arrhythmias (e.g., PVCs, bradycardia, etc.) at the time of enrollment.
Subject is allergic to adhesives or ECG gel.
Subject whose skin is not intact in or at the vicinity of the device placement site.

Trial locations and contacts

1 site in 1 country.

United States1 site

Site 1
Jackson, Tennessee, 38301

Other trials in United States

About this study

Conditions: Atrial Fibrillation
Being tested: 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.

INVSENSOR00057Device
Noninvasive wearable health monitoring device

Study groups in NCT05472012
Study group	Role	What they receive
INVSENSOR00057	Experimental	All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057 device. Receives: Device: INVSENSOR00057

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function
Afib detection accuracy will be determined by analyzing the sensitivity of INVSENSOR00057 Afib detection function when compared to data collected using a FDA-cleared ECG monitor.
Measured: 1-5 hours
Specificity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function
Afib detection accuracy will be determined by analyzing the specificity of INVSENSOR00057 Afib detection function when compared to data collected using a FDA-cleared ECG monitor.
Measured: 1-5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jul 202216 Dec 2023

First posted25 Jul 2022
Study start25 Jul 2022
Primary completion16 Dec 2023
Study completion16 Dec 2023

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 Atrial FibrillationStudies 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: 139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05472012
Sponsor's protocol ID: ROBI0001
Status last verified: May 2025
First submitted: 21 Jul 2022
Last updated: 22 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)
ClinicalTrials.gov ID: NCT05472012
Acronym / sponsor ID: ROBI0001
Conditions: Atrial Fibrillation
Study type: Interventional
Recruitment status: Completed
Enrolment: 139 participants (actual)
Lead sponsor: Masimo CorporationIndustry (pharma, biotech, devices)
Study start: 25 Jul 2022 (actual)
Primary completion: 16 Dec 2023 (actual)
Study completion: 16 Dec 2023 (actual)
First posted: 25 Jul 2022 (actual)
Results: Posted 22 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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: INVSENSOR00057All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057 device.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subject is 18 years of age or older.
Subject is confirmed to have active atrial fibrillation at the time of enrollment.

Key exclusion criteria (3 listed)

Subject is confirmed to have concurrent active arrhythmias (e.g., PVCs, bradycardia, etc.) at the time of enrollment.
Subject is allergic to adhesives or ECG gel.
Subject whose skin is not intact in or at the vicinity of the device placement site.

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
INVSENSOR00057Noninvasive wearable health monitoring device	Device	INVSENSOR00057

Primary outcome

Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function
Time frame: 1-5 hours
Afib detection accuracy will be determined by analyzing the sensitivity of INVSENSOR00057 Afib detection function when compared to data collected using a FDA-cleared ECG monitor.
Specificity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function
Time frame: 1-5 hours
Afib detection accuracy will be determined by analyzing the specificity of INVSENSOR00057 Afib detection function when compared to data collected using a FDA-cleared ECG monitor.

Results and safety

Results posted to the registry on 22 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
INVSENSOR00057	139	139

Primary outcome: Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function

Time frame: 1-5 hours. Number. Unit: % of true positive

Measure	INVSENSOR00057 n = 116
Value	96.97

Population analysed: A total of 23 subjects were excluded from the data analysis based on the protocol criteria. This included individuals whose reference or test ECG did not provide readable waveforms, as determined by medical personnel, and those who appeared to have atrial fibrillation (Afib) at enrollment but provided waveforms that were inconsistent with an Afib diagnosis.

Primary outcome: Specificity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function

Time frame: 1-5 hours. Number. Unit: % of true negative

Measure	INVSENSOR00057 n = 116
Value	100

Adverse events

Time frame: 1-5 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
INVSENSOR00057	0 of 139 (0%)	1 of 139 (0.7%)	0 of 139

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing INVSENSOR00057 in people with Atrial Fibrillation, run by Masimo Corporation at 1 site 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 2 inclusion and 3 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 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 22 May 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?

Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function (time frame: 1-5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05472012.

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 22 May 2025.