Clinical Calibration & Validation of a Next-Generation Blood Pressure Monitor for Patient Management (CCV)
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|ClinicalTrials.gov Identifier: NCT03015363|
Recruitment Status : Unknown
Verified February 2018 by Sohrab Lutchmedial, MD, FRCPC, Cardiovascular Research New Brunswick.
Recruitment status was: Active, not recruiting
First Posted : January 10, 2017
Last Update Posted : February 20, 2018
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Comparison, Calibration, and Validation of the Non-invasive Cloud DX Pulsewave Health MonitorTM With Direct Invasive Radial and Central Arterial Measurements During Cardiac Catheterization|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||December 2018|
- Systolic pressure [ Time Frame: Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure. ]
- Diastolic pressure [ Time Frame: Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure. ]
- Pulse rate [ Time Frame: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure. ]
- Breathing rate [ Time Frame: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015363
|Canada, New Brunswick|
|Horizon Health Network|
|Saint John, New Brunswick, Canada|
|Principal Investigator:||Sohrab Lutchmedial, MD, FRCPC||Cardiovascular Research New Brunswick|