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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. Wearable devices on the wrist, although emerging, are often not clinically validated or limited to the monitoring of one or two vital signs.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous measurement of photoplethysmography at the wrist | Device | Patients receive a wristband that uses multi-color LEDs to measure pulsations at the wrist. |
| Measure | Description | Time Frame |
|---|---|---|
| RMSE of Heart Rate | Root-mean-squared error between PPG measured and gold standard measured heart rate | 30 minutes |
| RMSE of Respiratory Rate | Root-mean-squared error between PPG measured and gold standard measured respiratory rate | 30 minutes |
| RMSE of Oxygen Saturation | Root-mean-squared error between PPG measured and gold standard measured oxygen saturation | 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) | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
Patients
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Patients admitted to coronary angiography
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reinier de Graaf Gasthuis | Delft | South Holland | 2625 AD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39388061 | Derived | 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. | |
| 38774367 | Derived |
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124 subjects undergoing heart catheterization were screened. 24 participants were not included due to:
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| ID | Title | Description |
|---|---|---|
| FG000 | Main Study Group | Subjects undergoing heart catheterization as standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Main Study Group | Subjects undergoing heart catheterization as standard of care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | RMSE of Heart Rate | Root-mean-squared error between PPG measured and gold standard measured heart rate | Posted | Mean | Full Range | beats per minute | 30 minutes | epochs (28 second) | epochs (28 second) |
|
|
During study intervention alone (during 1 hour study duration)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Main Study Group | Subjects undergoing heart catheterization as standard of care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Corsano Health B.V. | +31 61 640 7778 | info@corsano.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 4, 2022 | Nov 29, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Skin colour (Fitzpatrick) | Count of Participants | Participants |
|
| epochs (28 second) |
|
|
| Primary | RMSE of Respiratory Rate | Root-mean-squared error between PPG measured and gold standard measured respiratory rate | Posted | Mean | Full Range | breaths per minute | 30 minutes | epochs (28 second) | epochs (28 second) |
|
|
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| Primary | RMSE of Oxygen Saturation | Root-mean-squared error between PPG measured and gold standard measured oxygen saturation | Posted | Mean | Full Range | % of SpO2 | 30 minutes | epochs (28 second) | epochs (28 second) |
|
|
|
| Primary | RMSE of Blood Pressure | Root-mean-squared error between PPG measured and gold standard measured blood pressure (systolic blood pressure and diastolic blood pressure) | 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. | Posted | Mean | Standard Deviation | mmHg | 30 minutes | paired samples | paired samples |
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| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |