Atrial FibrillationRECAMONCT05899959
REmote CArdiac MOnitoring by the Corsano CardioWatch 287-2 Evaluation Study
An observational study of Atrial Fibrillation and Rhythm; Disorder, run by Corsano Health B.V. at 1 site in Netherlands.
Trial summary
In this study, a wristband that monitors hearth rhythm and blood pressure is assessed in free living conditions. Two groups of patients are being recruited: patients receiving an EKG holter and patients receiving an automatic blood pressure monitor. Patients wear the wristband for 28 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Rhythm; Disorder, Palpitations
- What is being tested?
- Corsano CardioWatch 287-2
- Type of treatment
- Medical device
- How many people
- 190 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Jun 2023to 28 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: One group (A) receiving an EKG monitoring holter for the duration of 24 hours as part of standard care for atrial fibrillation screening. Besides, one group (B) receiving an automatic blood pressure cuff for the duration of 24 hours as part of standard care for blood pressure evaluation.
Who may be able to join
- ≥ 18 years old;
- able to provide consent;
- receiving EKG holter or automatic blood pressure cuff for home monitoring per doctor prescription
Who cannot join
- Unable to wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
- Unable to receive blood pressure measurements per cuff due to lymphedema, amputation, dialysis shunt, wounds, etc.;
- Pregnant women;
- Breastfeading women;
- Upper arm circumference not within the cuff range (22-42 cm)
- Unable or not willing to sign informed consent;
- Significant mental or cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Cardiac Monitoring by the Corsano CardioWatch 287-2 Evaluation Study
In this study, a wristband that monitors hearth rhythm and blood pressure is assessed in free living conditions.
Two groups of patients are being recruited: patients receiving an EKG holter and patients receiving an automatic blood pressure monitor. Patients wear the wristband for 28 days. During this time, the number of atrial fibrillation episodes detected by the wristband is being counted, which is to be compared with the number of episodes detected by the holter. Also, blood pressure is measured continuously, which is to be compared with daily blood pressure measurements using a conventional blood pressure cuff.
Read the detailed description
Background of the study:
Wearables have the potential to monitor patients remotely. The Corsano CardioWatch 287-2 is such a medical device that can monitor atrial fibrillation and long-term blood pressure. The device has been validated using clinical trials in hospitals, but validation in the intended remote setting is lacking.
Objective of the study:
Primary objective: To compare the number of episodes of atrial fibrillation detected by the Corsano CardioWatch 287-2 during 28 days of use with the number of episodes of atrial fibrillation detected by conventional Holter monitoring during 48 hours of use (standard care).
Secondary objective: To assess the difference in blood pressure measurements obtained by the Corsano CardioWatch 287-2 and the conventional cuff blood pressure monitor over a period of 28 days; to assess the usability of the Corsano CardioWatch 287-2 from a patient perspective.
Study design:
Group A:
Conventional 24 hour EKG holter monitoring will be compared to 28 day continuous monitoring by the Corsano CardioWatch 287-2 to assess whether the percentage of patients in whom atrial fibrillation is detected will increase. Detection of atrial fibrillation with the Corsano CardioWatch 287-2 is done by optical photoplethysmography (PPG), after which atrial fibrillation is confirmed with a 30-second ECG measurement.
Additionally, conventional cuff blood pressure will be compared to blood pressure measured by the Corsano CardioWatch 287-2 to validate free-living blood pressure monitoring. Patients will measure their blood pressure daily with a cuff blood pressure measurement device. The measurements at day 7, 14, 21 will be used to reinforce the Corsano blood pressure algorithm. The remaining measurements will be used to compare the blood pressure with the values measured by the Corsano CardioWatch 287-2 to assess accuracy.
Group B:
Conventional automatic cuff blood pressure measurement will be compared with the Corsano CardioWatch 287-2 for 24-48 hours. The automatic cuff blood pressure monitor will take a blood pressure reading every 30 minutes. Each reading will be compared with the Corsano CardioWatch 287-2 reading.
Study population:
Patients receiving a 24 hour EKG holter or an ambulant blood pressure device after visiting the cardiologist's outpatient clinic.
Primary study parameters/outcome of the study:
Absolute percentage increase of patients in whom at least one event of atrial fibrillation is detected by the Corsano CardioWatch 287-2 during 28 days of monitoring, compared to a conventional EKG holter during 24-48 hours of monitoring.
Secundary study parameters/outcome of the study (if applicable):
- Mean blood pressure difference and its SD between blood pressure measured by the Corsano CardioWatch 287-2 and blood pressure measured by a conventional oscillometric blood pressure cuff.
- Usability of the Corsano CardioWatch 287-2 in a remote care setting as determined by a questionnaire.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
At the cardiologist's office, Group A and B patients receive 3 blood pressure measurements. These are performed by a nurse. Group A will take daily blood pressure readings of themselves at home. If atrial fibrillation is detected by the wristband, Group A patients will be asked to take an ECG. Finally, Group A patients will be asked once to complete a questionnaire. Group B only has to wear the wristband for 24 to 48 hours as an additional burden in addition to the aforementioned initial measurements.
- Conditions
- Atrial Fibrillation, Rhythm; Disorder, Palpitations, Hypertension, Hypotension
- Being tested
- Corsano CardioWatch 287-2
- Keywords
- wristband, wearable, blood pressure, ekg, atrial fibrillation, hypertension, comparison
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Hypertension, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corsano CardioWatch 287-2Device
Patients receive either an EKG holter or an automatic blood pressure cuff, as prescribed by their cardiologist. The readings from these devices (atrial fibrillation detection and blood pressure) will be compared to the readings from the CardioWatch 287-2.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving an EKG holter | patients receiving an EKG holter at the outpatient clinic for 24-48 hours of remote monitoring Receives: Device: Corsano CardioWatch 287-2 | |
| Patients receiving an automatic blood pressure cuff | patients receiving an automatic blood pressure cuff at the outpatient clinic for 24 hours of remote monitoring Receives: Device: Corsano CardioWatch 287-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation detection rate
Absolute percentage increase of patients in whom at least one event of atrial fibrillation is detected by the Corsano CardioWatch 287-2 during 28 days of monitoring, compared to a conventional EKG holter during 24-48 hours of monitoring.
Measured: 28 days
Blood pressure accuracy
Mean systolic and diastolic blood pressure difference and its SD between blood pressure measured by the Corsano CardioWatch 287-2 and blood pressure measured by a conventional oscillometric blood pressure cuff.
Measured: 28 days (EKG holter group) or 1-2 days (Automatic blood pressure group)
Secondary outcomes (2)
Blood pressure accuracy
Bias and limits of agreement between systolic and diastolic blood pressure measured by the Corsano CardioWatch 287-2 and blood pressure measured by a conventional oscillometric blood pressure cuff.
Measured: 28 days (EKG holter group) or 1-2 days (Automatic blood pressure group)
Usability questionnaire
Usability of the Corsano CardioWatch 287-2 in a remote care setting as assessed by a self-developed questionnaire
Measured: 28 days (EKG holter group) or 1-2 days (Automatic blood pressure group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start15 Jun 2023
- Primary completion28 Dec 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corsano Health B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899959
- Sponsor's protocol ID
- RECAMO
- Acronym
- RECAMO
- Status last verified
- Aug 2024
- First submitted
- 2 Jun 2023
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Vliet M, Aalberts JJJ, Hamelinck C, Hauer AD, Hoftijzer D, Monnink SHJ, Schipper JC, Constandse JC, Peters NS, Lip GYH, Steinhubl SR, Ronner E. Assessment of photoplethysmography-based blood pressure determinations during long-term and short-term remote cardiac monitoring: the RECAMO study. Eur Heart J Digit Health. 2025 Mar 27;6(4):763-771. doi: 10.1093/ehjdh/ztaf027. eCollection 2025 Jul.
PubMed 40703134van Vliet M, Aalberts JJJ, Hamelinck C, Hauer AD, Hoftijzer D, Monnink SHJ, Schipper JC, Constandse JC, Peters NS, Lip GYH, Steinhubl SR, Ronner E. Ambulatory atrial fibrillation detection and quantification by wristworn AI device compared to standard holter monitoring. NPJ Digit Med. 2025 Mar 25;8(1):177. doi: 10.1038/s41746-025-01555-9.
PubMed 40133622
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Cardiac Monitoring by the Corsano CardioWatch 287-2 Evaluation Study
- ClinicalTrials.gov ID
- NCT05899959
- Acronym / sponsor ID
- RECAMO / RECAMO
- Conditions
- Atrial Fibrillation, Rhythm; Disorder, Palpitations, Hypertension, Hypotension
- Keywords
- wristband, wearable, blood pressure, ekg, atrial fibrillation, hypertension, comparison
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Corsano Health B.V.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, a wristband that monitors hearth rhythm and blood pressure is assessed in free living conditions.
Two groups of patients are being recruited: patients receiving an EKG holter and patients receiving an automatic blood pressure monitor. Patients wear the wristband for 28 days. During this time, the number of atrial fibrillation episodes detected by the wristband is being counted, which is to be compared with the number of episodes detected by the holter. Also, blood pressure is measured continuously, which is to be compared with daily blood pressure measurements using a conventional blood pressure cuff.
Detailed description
Background of the study:
Wearables have the potential to monitor patients remotely. The Corsano CardioWatch 287-2 is such a medical device that can monitor atrial fibrillation and long-term blood pressure. The device has been validated using clinical trials in hospitals, but validation in the intended remote setting is lacking.
Objective of the study:
Primary objective: To compare the number of episodes of atrial fibrillation detected by the Corsano CardioWatch 287-2 during 28 days of use with the number of episodes of atrial fibrillation detected by conventional Holter monitoring during 48 hours of use (standard care).
Secondary objective: To assess the difference in blood pressure measurements obtained by the Corsano CardioWatch 287-2 and the conventional cuff blood pressure monitor over a period of 28 days; to assess the usability of the Corsano CardioWatch 287-2 from a patient perspective.
Study design:
Group A:
Conventional 24 hour EKG holter monitoring will be compared to 28 day continuous monitoring by the Corsano CardioWatch 287-2 to assess whether the percentage of patients in whom atrial fibrillation is detected will increase. Detection of atrial fibrillation with the Corsano CardioWatch 287-2 is done by optical photoplethysmography (PPG), after which atrial fibrillation is confirmed with a 30-second ECG measurement.
Additionally, conventional cuff blood pressure will be compared to blood pressure measured by the Corsano CardioWatch 287-2 to validate free-living blood pressure monitoring. Patients will measure their blood pressure daily with a cuff blood pressure measurement device. The measurements at day 7, 14, 21 will be used to reinforce the Corsano blood pressure algorithm. The remaining measurements will be used to compare the blood pressure with the values measured by the Corsano CardioWatch 287-2 to assess accuracy.
Group B:
Conventional automatic cuff blood pressure measurement will be compared with the Corsano CardioWatch 287-2 for 24-48 hours. The automatic cuff blood pressure monitor will take a blood pressure reading every 30 minutes. Each reading will be compared with the Corsano CardioWatch 287-2 reading.
Study population:
Patients receiving a 24 hour EKG holter or an ambulant blood pressure device after visiting the cardiologist's outpatient clinic.
Primary study parameters/outcome of the study:
Absolute percentage increase of patients in whom at least one event of atrial fibrillation is detected by the Corsano CardioWatch 287-2 during 28 days of monitoring, compared to a conventional EKG holter during 24-48 hours of monitoring.
Secundary study parameters/outcome of the study (if applicable):
- Mean blood pressure difference and its SD between blood pressure measured by the Corsano CardioWatch 287-2 and blood pressure measured by a conventional oscillometric blood pressure cuff.
- Usability of the Corsano CardioWatch 287-2 in a remote care setting as determined by a questionnaire.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
At the cardiologist's office, Group A and B patients receive 3 blood pressure measurements. These are performed by a nurse. Group A will take daily blood pressure readings of themselves at home. If atrial fibrillation is detected by the wristband, Group A patients will be asked to take an ECG. Finally, Group A patients will be asked once to complete a questionnaire. Group B only has to wear the wristband for 24 to 48 hours as an additional burden in addition to the aforementioned initial measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving an EKG holter | – | Device: Corsano CardioWatch 287-2patients receiving an EKG holter at the outpatient clinic for 24-48 hours of remote monitoring |
| Patients receiving an automatic blood pressure cuff | – | Device: Corsano CardioWatch 287-2patients receiving an automatic blood pressure cuff at the outpatient clinic for 24 hours of remote monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One group (A) receiving an EKG monitoring holter for the duration of 24 hours as part of standard care for atrial fibrillation screening. Besides, one group (B) receiving an automatic blood pressure cuff for the duration of 24 hours as part of standard care for blood pressure evaluation.
Key inclusion criteria (3 listed)
- ≥ 18 years old;
- able to provide consent;
- receiving EKG holter or automatic blood pressure cuff for home monitoring per doctor prescription
Key exclusion criteria (7 listed)
- Unable to wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
- Unable to receive blood pressure measurements per cuff due to lymphedema, amputation, dialysis shunt, wounds, etc.;
- Pregnant women;
- Breastfeading women;
- Upper arm circumference not within the cuff range (22-42 cm)
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 |
|---|---|---|
| Corsano CardioWatch 287-2Patients receive either an EKG holter or an automatic blood pressure cuff, as prescribed by their cardiologist. The readings from these devices (atrial fibrillation detection and blood pressure) will be compared to the readings from the CardioWatch 287-2. | Device | Patients receiving an EKG holter, Patients receiving an automatic blood pressure cuff |
Primary outcome
Atrial fibrillation detection rate
Time frame: 28 days
Absolute percentage increase of patients in whom at least one event of atrial fibrillation is detected by the Corsano CardioWatch 287-2 during 28 days of monitoring, compared to a conventional EKG holter during 24-48 hours of monitoring.
Blood pressure accuracy
Time frame: 28 days (EKG holter group) or 1-2 days (Automatic blood pressure group)
Mean systolic and diastolic blood pressure difference and its SD between blood pressure measured by the Corsano CardioWatch 287-2 and blood pressure measured by a conventional oscillometric blood pressure cuff.
2 secondary outcomes
Blood pressure accuracy
Time frame: 28 days (EKG holter group) or 1-2 days (Automatic blood pressure group)
Usability questionnaire
Time frame: 28 days (EKG holter group) or 1-2 days (Automatic blood pressure group)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Derived from this study: PubMed 40703134van Vliet M, Aalberts JJJ, Hamelinck C, Hauer AD, Hoftijzer D, Monnink SHJ, Schipper JC, Constandse JC, Peters NS, Lip GYH, Steinhubl SR, Ronner E. Assessment of photoplethysmography-based blood pressure determinations during long-term and short-term remote cardiac monitoring: the RECAMO study. Eur Heart J Digit Health. 2025 Mar 27;6(4):763-771. doi: 10.1093/ehjdh/ztaf027. eCollection 2025 Jul.
- Derived from this study: PubMed 40133622van Vliet M, Aalberts JJJ, Hamelinck C, Hauer AD, Hoftijzer D, Monnink SHJ, Schipper JC, Constandse JC, Peters NS, Lip GYH, Steinhubl SR, Ronner E. Ambulatory atrial fibrillation detection and quantification by wristworn AI device compared to standard holter monitoring. NPJ Digit Med. 2025 Mar 25;8(1):177. doi: 10.1038/s41746-025-01555-9.
- 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 Atrial Fibrillation and Rhythm; Disorder, 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 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 26 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Atrial fibrillation detection rate (time frame: 28 days). 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 NCT05899959, 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 26 Aug 2024.