Multi-Centre Based Evaluation of the Performance and Safety of the Corsano CardioWatch 287-2 Blood Pressure Monitoring Device at Wrist Against BP-Cuff Measurements (COR-BP)

Обзор

The Corsano CardioWatch 287-2 is a medical wearable device that can monitor blood pressure. The device has been validated using clinical trials in hospitals. The aim of this study is to further evaluate blood pressure measurements by the CardioWatch 287-2 in the intended remote setting across various demographic groups. Primary objective: To assess the difference in blood pressure measurements obtained by the Corsano CardioWatch 287-2 and auscultatory blood pressure monitoring over a period of 31 days. Secondary objective: To assess the usability of the Corsano CardioWatch 287-2 from a patient perspective. Participants receiving multiple standardized paired auscultatory and Corsano CardioWatch blood pressure measurements over a 31-day period. The study group will include patients of different ages (above the age of 22 years), genders, and demographics.

Вмешательства

• Устройство Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2
  Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2 wearable over a period of 31 days.
• Диагностический тест Auscultatory blood pressure measurement
  Auscultatory blood pressure measurements in supine and sitting position.

Первичные конечные точки

• Validate blood pressure measurements Corsano CardioWatch 287-2 [Срок оценки: 31 days]

Вторичные конечные точки (1)

• Assess usability [Срок оценки: 31 days]

Критерии участия

Критерии включения

• Participants must be able to provide informed consent to participate.
• Participants must be willing and able to comply with all of the study procedures and return for at least 3 visits.
• Participant or witness must be able to read or write in Dutch or English.
• Applicable for group A: Participant must be 22 to 50 years of age.
• Applicable for group B: Participant must be over 50 years of age.

Критерии исключения

• Participants with compromised circulation, injury, or physical malformation of the equipment test sites or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized).
• Female participants who are known to be pregnant or who are trying to get pregnant confirmed by a day 1 positive urine pregnancy test unless the study participant is known to be not of child-bearing potential.
• Participants with known clotting disorders or currently taking a prescription blood thinner.
• Other known health conditions that will prevent safe participation in the study upon disclosure in Health Assessment Short Form or verbally.
• Participants suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest > 120bpm) and atrial fibrillation.
• Participants suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 60mL / min / 1.73 m2), hyper- / hypothyroidism, pheochromocytoma or arteriovenous fistula.
• Participants with known aortic arch pathology or prior surgical intervention involving the aortic arch or descending aorta (e.g., coarctation repair, vascular grafting, or stenting), which may interfere either with accurate peripheral blood pressure measurement.
• A wrist circumference below 14 cm or above 23 cm.
• An upper arm circumference < 22cm or > 42cm.
• Any subject that, in the opinion of the investigator, does not exhibit any phenotype relevant to the objectives of this study (i.e. to ensure all sub-groups have adequate representation).
• Any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, bias the results, by instance a subject presenting a lateral Blood Pressure difference at screening of more than 15 mmHg for the systolic and/or more than 10 mmHg for the diastolic.

Additional criteria that will be pursued for ensuring demographic diversity consist of the following patient characteristics according to FDA recommendations concerning the diversity of clinical trial populations \[6\]:

• Gender, at least:

• 40% female;
• 40% male.
• Skin Colour, at least:

• 25% Monk skin tone (MST) 1-3;
• 25% MST 4-6;
• 25% MST 7-10 including subjects with MST 9 and MST 10.
• BMI, at least:

• 5% Underweight (<18.5)
• 20% Normal weight (18.5-24.9)
• 20% Overweight (25-29.9)
• 20% Obese (≥30.0)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07633886 · COR-BP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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