Clinical Calibration & Validation of a Next-Generation Blood Pressure Monitor for Patient Management

Study Overview
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Brief Summary
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The objective of the Cloud DX Pulsewave Health Monitor study is to prospectively calibrate and validate a novel, non-invasive wrist cuff blood pressure device against the gold standard for hemodynamic monitoring (intra-arterial pressure) in voluntarily consented patient participants who are scheduled for an elective cardiac catheterization procedure for clinically valid reasons.

Detailed Description
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The Cloud DX Pulsewave Health Monitor is a non-invasive wrist cuff blood pressure device that is licensed by Health Canada with Food and Drug Administration approval. Systolic and diastolic pressures are measured via the arterial pulse waveform of the left radial artery. Initially, the blood pressure algorithm was created and calibrated using the auscultatory method. The purpose of this study is to calibrate the device to the clinical gold standard of peripheral and central intra-arterial pressures. The device acquires a pulse signal in real-time, stores signal and measurement data, and displays stored signal and measurement data for interpretation via internet servers where it is accessible by end-users (physicians and/or patients). The system provides secure accounts for both in-patient and out-patient monitoring. Cloud DX's Pulsewave Health Monitor servers are housed in a secure data center. Privacy measures are to SSAE16 SOC-1 Type-II compliance: 1) restricted secure access, 2) dedicated firewall, 3) HTTPS channel communication via website, 4) self-encrypting hard-drives rendered useless if removed from the server.

Official Title
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Comparison, Calibration, and Validation of the Non-invasive Cloud DX Pulsewave Health MonitorTM With Direct Invasive Radial and Central Arterial Measurements During Cardiac Catheterization

Conditions
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Hypertension

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 19 years of age Patients recommended by their cardiologist for a first-time, elective cardiac catheterization procedure Wrist circumference between 13.5cm - 23cm (5.3 - 9.1in.) Bilateral arm blood pressure equality (systolic within ±10mmHg; diastolic within ±5mmHg) on 2 separate readings (Nurse Associate & TRA) Willing to volunteer to participate and to sign the study specific informed consent form Exclusion Criteria: No history of peripheral vascular disease, no previous percutaneous coronary intervention, nor previous coronary artery bypass graft No arrhythmia No abdominal aortic aneurysm No hand/body tremor

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Pressure | Central aortic pressure (mmHg) | Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure. | 
| Diastolic Pressure | Central aortic pressure (mm Hg) | Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure. | 
| Systolic Pressure | Peripheral arterial pressure (mm Hg) | Non-invasive blood pressure device measurements on day of cardiac catheterization procedure. | 
| Diastolic Pressure | Peripheral arterial pressure (mm Hg) | Non-invasive blood pressure device measurements on day of cardiac catheterization procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Telemonitoring, Vital signs