Evaluation of a Non-Invasive Electrocardiogram-Assisted Blood Pressure Monitor
|ClinicalTrials.gov Identifier: NCT02053623|
Recruitment Status : Terminated (Technical issues & lack of funds)
First Posted : February 3, 2014
Last Update Posted : February 24, 2017
Approximately one billion people suffer from hypertension worldwide. At least 10% of this population, that is, 100 million people, also suffers from associated chronic conditions namely, atrial fibrillation (AF), obesity, arterial stiffness (AS), and heart failure (HF). Personal interaction with medical practitioners (doctors) and review of published clinical research confirms that current non-invasive automatic blood pressure (BP) monitors that rely on BP pulse analysis alone cannot provide accurate measurement due to the unpredictable/weak nature of BP pulses in the above-mentioned chronic conditions. Lack of accuracy in BP estimation can lead to wrong diagnoses and hence to complications such as stokes and heart attacks.
The Sponsor is developing a novel non-invasive BP monitor that is similar to existing automatic monitors yet is capable of acquiring and analyzing electrocardiogram (ECG) data in conjunction with BP pulse data to provide better and more accurate measurements in the above chronic conditions.
The objective of this clinical trial is to evaluate the performance of this ECG-assisted BP monitor against invasive BP measurements in a small group of patients who suffer from the above conditions.
|Condition or disease|
|Hypertension Atrial Fibrillation Obesity Heart Failure Atherosclerosis|
|Study Type :||Observational|
|Actual Enrollment :||3 participants|
|Official Title:||Evaluation of a Novel Non-Invasive Electrocardiogram-Assisted Blood Pressure Monitor Against Invasive Intra-Arterial Pressure Monitoring - A Pilot Study|
|Actual Study Start Date :||April 2, 2015|
|Actual Primary Completion Date :||May 21, 2015|
|Actual Study Completion Date :||July 2, 2015|
- Accurate and Consistent Blood Pressure Measurement [ Time Frame: 12 months ]We expect to demonstrate that our automated non-invasive ECG-assisted BP monitoring technology can provide accurate and consistent diastolic & systolic pressure measurements in chronic patient conditions (namely AF, obesity, AS, and HF) in which current non-invasive oscillometric technologies tend to be unreliable.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02053623
|University of Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y 4W7|