Coronary Artery DiseaseMULTI-VITALNCT05566886

Validation of a Vital Signs Monitoring Wristband

An observational study of Coronary Artery Disease, run by Corsano Health B.V. at 1 site in Netherlands.

Completed

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

Trial summary

Today, continuous monitoring of vital signs remains a challenge since it generally requires the patient to be connected to multiple wired sensors, which restricts patient mobility in the intra-mural setting and complicates home monitoring in the extra-mural setting. Read more about this study

Who is it for?: Any age
Conditions the study is for: Coronary Artery Disease
What is being tested?: Continuous measurement of photoplethysmography at the wrist
Type of treatment: Medical device
How many people: 100 participants
Where: 1 siteNetherlands
Study dates: 19 Oct 2022to 7 Feb 2023
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients admitted to coronary angiography

Who may be able to join

18 years old;
undergoing invasive monitoring, like coronary angiography;
able to provide consent.

Who cannot join

Patients
who cannot wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
unable or not willing to sign informed consent;
with significant mental or cognitive impairment;
who do not have a suitable entry site for the invasive arterial line
who do not comply to criteria established by ISO 81060-2:2018.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Reinier de Graaf Gasthuis
Delft, South Holland, 2625 AD

Other trials in Netherlands

About this study

Official title: Multi Parameter Vital Signs Monitoring by the Corsano CardioWatch 287-2 Validation Study

This study aims to validate the Corsano CardioWatch 287-2 for the continuous monitoring of heart rate at ≤ 4 bpm root mean squared error (RMSE); interbeat intervals at ≤ 50 ms RMSE; breathing rate at ≤ 2 brpm RMSE; and peripheral oxygen saturation at ≤ 3 percentage point RMSE. Also, this study aims to validate the Corsano CardioWatch 287-2 for the measurement of non-invasive blood pressure according to ISO 81060-2:2018.

Conditions: Coronary Artery Disease
Being tested: Continuous measurement of photoplethysmography at the wrist
Keywords: Vital signs, Blood pressure, Oxygen saturation, Heart rate, Respiratory rate
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Continuous measurement of photoplethysmography at the wristDevice
Patients receive a wristband that uses multi-color LEDs to measure pulsations at the wrist.

What is being measured

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

RMSE of Heart Rate
Root-mean-squared error between PPG measured and gold standard measured heart rate
Measured: 30 minutes
RMSE of Respiratory Rate
Root-mean-squared error between PPG measured and gold standard measured respiratory rate
Measured: 30 minutes
RMSE of Oxygen Saturation
Root-mean-squared error between PPG measured and gold standard measured oxygen saturation
Measured: 30 minutes
RMSE of Blood Pressure
Root-mean-squared error between PPG measured and gold standard measured blood pressure (systolic blood pressure and diastolic blood pressure)
Measured: 30 minutes

Timeline

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

19 Oct 20227 Feb 2023

First posted4 Oct 2022
Study start19 Oct 2022
Primary completion7 Feb 2023
Study completion7 Feb 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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05566886
Sponsor's protocol ID: MULTI-VITAL
Acronym: MULTI-VITAL
Status last verified: Apr 2025
First submitted: 20 Sep 2022
Last updated: 4 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Monnink SHJ, van Vliet M, Kuiper MJ, Constandse JC, Hoftijzer D, Muller M, Ronner E. Clinical evaluation of a smart wristband for monitoring oxygen saturation, pulse rate, and respiratory rate. J Clin Monit Comput. 2025 Apr;39(2):451-457. doi: 10.1007/s10877-024-01229-z. Epub 2024 Oct 10.
PubMed 39388061
van Vliet M, Monnink SHJ, Kuiper MJ, Constandse JC, Hoftijzer D, Ronner E. Evaluation of a novel cuffless photoplethysmography-based wristband for measuring blood pressure according to the regulatory standards. Eur Heart J Digit Health. 2024 Feb 8;5(3):335-343. doi: 10.1093/ehjdh/ztae006. eCollection 2024 May.
PubMed 38774367

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

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All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi Parameter Vital Signs Monitoring by the Corsano CardioWatch 287-2 Validation Study
ClinicalTrials.gov ID: NCT05566886
Acronym / sponsor ID: MULTI-VITAL / MULTI-VITAL
Conditions: Coronary Artery Disease
Keywords: Vital signs, Blood pressure, Oxygen saturation, Heart rate, Respiratory rate
Study type: Observational
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Corsano Health B.V.Industry (pharma, biotech, devices)
Study start: 19 Oct 2022 (actual)
Primary completion: 7 Feb 2023 (actual)
Study completion: 7 Feb 2023 (actual)
First posted: 4 Oct 2022 (actual)
Results: Posted 4 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

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients admitted to coronary angiography

Key inclusion criteria (3 listed)

18 years old;
undergoing invasive monitoring, like coronary angiography;
able to provide consent.

Key exclusion criteria (6 listed)

Patients
who cannot wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
unable or not willing to sign informed consent;
with significant mental or cognitive impairment;
who do not have a suitable entry site for the invasive arterial line

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
Continuous measurement of photoplethysmography at the wristPatients receive a wristband that uses multi-color LEDs to measure pulsations at the wrist.	Device	–

Primary outcome

RMSE of Heart Rate
Time frame: 30 minutes
Root-mean-squared error between PPG measured and gold standard measured heart rate
RMSE of Respiratory Rate
Time frame: 30 minutes
Root-mean-squared error between PPG measured and gold standard measured respiratory rate
RMSE of Oxygen Saturation
Time frame: 30 minutes
Root-mean-squared error between PPG measured and gold standard measured oxygen saturation
RMSE of Blood Pressure
Time frame: 30 minutes
Root-mean-squared error between PPG measured and gold standard measured blood pressure (systolic blood pressure and diastolic blood pressure)

Results and safety

Results posted to the registry on 4 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
Main Study Group	100	100

Primary outcome: RMSE of Heart Rate

Time frame: 30 minutes. Mean (Full Range). Unit: beats per minute

Measure	Main Study Group n = 100
Value	1.3 (-5.5 to 4.2)

Primary outcome: RMSE of Respiratory Rate

Time frame: 30 minutes. Mean (Full Range). Unit: breaths per minute

Measure	Main Study Group n = 100
Value	0.9 (-2.1 to 2)

Primary outcome: RMSE of Oxygen Saturation

Time frame: 30 minutes. Mean (Full Range). Unit: % of SpO2

Measure	Main Study Group n = 100
Value	1.6 (-3.2 to 3.9)

Primary outcome: RMSE of Blood Pressure

Time frame: 30 minutes. Mean (Standard Deviation). Unit: mmHg

Measure	Main Study Group n = 97
Systolic Blood Pressure	3.7 (4.4)
Diastolic Blood Pressure	2.5 (3.7)

Population analysed: 100 subjects were included, however, 3 individuals did not meet pre-specified dampening criteria As a result data of 97 patients and 420 measurement pairs was included in the analysis.

Adverse events

Time frame: During study intervention alone (during 1 hour study duration). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Main Study Group	0 of 100 (0%)	0 of 100 (0%)	0 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39388061Monnink SHJ, van Vliet M, Kuiper MJ, Constandse JC, Hoftijzer D, Muller M, Ronner E. Clinical evaluation of a smart wristband for monitoring oxygen saturation, pulse rate, and respiratory rate. J Clin Monit Comput. 2025 Apr;39(2):451-457. doi: 10.1007/s10877-024-01229-z. Epub 2024 Oct 10.
Derived from this study: PubMed 38774367van Vliet M, Monnink SHJ, Kuiper MJ, Constandse JC, Hoftijzer D, Ronner E. Evaluation of a novel cuffless photoplethysmography-based wristband for measuring blood pressure according to the regulatory standards. Eur Heart J Digit Health. 2024 Feb 8;5(3):335-343. doi: 10.1093/ehjdh/ztae006. eCollection 2024 May.
Individual participant dataSharing planned: No

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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.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Corsano Health B.V. at 1 site in Netherlands.

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 3 inclusion and 6 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 4 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 Netherlands. 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 4 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?

RMSE of Heart Rate (time frame: 30 minutes). The study lists 4 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 NCT05566886, which also lists 2 linked publications.

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 4 May 2025.